Establishing a successful outpatient CAR T-Cell program with cilta-cel: real-world experience from an expert roundtable.

Introduction

Chimeric antigen receptor T-cell (CAR-T) therapy is a significant advancement in hematologic malignancy management. In the US, CAR-T therapy was initially approved for patients with heavily pretreated leukemias and lymphomas. The US Food and Drug Administration (FDA) mandated inpatient administration at specialized treatment centers, followed by close monitoring for serious events such as cytokine release syndrome (CRS) and neurotoxicity [ 1 ]. However, CAR-T therapy administration was complicated by patient selection, coordination of care across health care providers, limited number of beds, and management of potential adverse events (AEs) [ 2 , 3 ]. In less than a decade since the first approval, the safety profiles of individual CAR-T agents are better understood and managed, with established protocols to monitor, manage, and quickly intervene for potential AEs, as well as to meet patient preferences [ 1 , 4–6 ]. Today, CAR-T therapy has expanded with broader indications, administration earlier in the disease course, and the development of successful outpatient administration programs at select experienced centers [ 4–9 ]. The trajectory of approval and shift from inpatient to outpatient administration has been similar to that of autologous bone marrow transplant (BMT). Today, outpatient autologous BMT is widely accepted in appropriate clinical scenarios and is associated with improved health outcomes and patient quality of life, reduced overall costs and hospital stays, and enhanced safety and effectiveness [ 10 , 11 ].

Multiple centers have demonstrated that with appropriate infrastructure planning, outpatient administration of CAR-T therapy for appropriate patients is safe, efficacious, and feasible [ 4 , 5 , 7–9 , 12 ]. Potential institutional benefits of outpatient CAR-T programs may include better logistical management, conservation of institutional resources, increased treatment capacity, shorter patient hospitalization times, alleviating inpatient departmental staffing concerns, and reducing costs [ 1 , 7 , 9 , 12 , 13 ]. Patient benefits of outpatient CAR-T programs may include avoiding the inconvenience of an elective or prolonged admission, reducing the risk of a nosocomial infection, spending more time at home and outside the hospital, improving quality of life, and reducing the associated financial burden [ 1 , 7 , 12 , 14 ].

Ciltacabtagene autoleucel (cilta-cel) is a CAR-T therapy approved by the FDA based on the CARTITUDE-4 study for the treatment of adult patients with relapsed or refractory MM who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide [ 15–17 ]. Along with other CAR-T therapies, cilta-cel is being used as early as after first relapse for appropriate patients with MM [ 15 , 16 ]. This earlier use, combined with a predictably delayed immune-mediated toxicity profile, has increased demand for cilta-cel, making it a prime candidate for outpatient administration programs. With cilta-cel, CRS typically occurs between 7 and 8 days after infusion (vs 1–3 days with other CAR-T therapies such as idecabtagene vicleucel and axicabtagene ciloleucel), and the onset of immune effector cell – associated neurotoxicity syndrome (ICANS) occurs at a median of 7 to 9.5 days after infusions (vs 2–3 days for idecabtagene vicleucel and tisagenlecleucel). Corticosteroid prophylaxis is not required for cilta-cel administration [ 15 , 18–22 ].

Outpatient administration programs with cilta-cel have been successful and have the potential to be more widely adopted. Given that some health care systems have moved to primarily offering CAR-T therapy in the outpatient setting, the distinguishing attributes that set cilta-cel apart from other CAR-T therapies, and the increasing patient demand for CAR-T therapy, sharing strategies for establishing a successful cilta-cel outpatient administration program is becoming a critical part of ensuring all appropriate patients have timely access to cilta-cel. Notably, while outpatient administration of cilta-cel has been an option in some of the CARTITUDE clinical studies, details for only two of such patients have been published [ 23 ]. This article provides an overview of the real-world experience of five hematology/oncology experts involved with cilta-cel outpatient programs at their institutions, where outpatient administration of cilta-cel has been feasible and safe. Their experience is outlined and shared as institutional- and patient-related success factors for any clinic that would like to explore a practical approach to establishing an effective and safe outpatient cilta-cel program ( Figure 1 ). Figure 1. Success factors for initiating an outpatient cilta-cel administration Program.

Methods

Five hematology/oncology leaders with expertise in myeloma and cellular therapies met in Boston, Massachusetts on 22 March 2024, to participate in a 2-hour roundtable. Experts chosen to participate in the roundtable were required to have experience administering cilta-cel in the outpatient setting to at least 15 patients. The aim to have geographic and institutional (academic medical center, comprehensive cancer center, community-based treatment center) diversity represented was achieved with overall demographics described in Table 1 . Table 1. Participant and institution demographics. Participant Institution Name Clinic City and State Type of Institution Estimated Number of Patients with RRMM Treated in the Cilta-Cel Outpatient Program Alsina H. Lee Moffitt Cancer Center and Research Institute Tampa, FL Comprehensive cancer center >75 Dhakal Medical College of Wisconsin Milwaukee, WI Academic medical center 16–30 Pantin Sarah Cannon Transplant and Cellular Therapy Network Nashville, TN Community-based treatment center 1–15 Huff Johns Hopkins University School of Medicine Baltimore, MD Academic medical center 16–30 Janakiram City of Hope Duarte, CA Comprehensive cancer center 31–50 Cilta-cel, ciltacabtagene-autoleucel; RRMM, relapsed/refractory multiple myeloma.

A premeeting survey was completed by participants to provide insight into local institutional practices; a copy of the survey can be found in the appendix (Table S1). For the purposes of the roundtable and this manuscript, the outpatient setting was defined as the period of lymphodepletion, infusion of cilta-cel or other CAR-T therapy, and subsequent monitoring.

Expert recommendations

This group of five hematology/oncology experts shared six critical success factors related to institutional infrastructure, three critical success factors related to patients, and three noncritical considerations for the development of an outpatient cilta-cel administration program.

Institutional infrastructure critical to the success of an outpatient cilta-cel program

Critical success factor: ensure adequate staffing and hospital bed access

Originally, we had our patients coming in in the morning and then a nurse calling in the evening. We stopped the evening phone call as we found it was unnecessary. The patients or caregiver call when something is wrong or there is a change. Dr Alsina

Patients should have access to a dedicated and knowledgeable health care provider 24 hours per day, 7 days per week. Residents, attendings, oncologic hospitalists, and other staff can be utilized to meet staffing needs. Programs should consider including advanced practice providers (APPs) and utilizing staffing redundancy to ensure continuity of care [ 24 ]. An example staffing plan may include dedicated APPs seeing patients from the outpatient cilta-cel program daily on weekdays, days 1 through 10 post-infusion, with attendings seeing patients on the day of infusion, on day 4 post-infusion, and on the weekends. Similarly, patients should have access to a ready hospital bed 24 hours per day, 7 days per week. One dedicated hospital bed could be assigned to the outpatient cilta-cel program and be ready for patients as needed, with considerations for additional beds based on expected patient volume of the outpatient program.

Clear communication and directives may be established by the institution for admitting patients to the assigned cilta-cel program hospital bed. Patients may be admitted directly through the oncology clinic or the emergency department (ED), depending on site admission processes. It is imperative to establish and ensure appropriate communication between the ED and the hematology/oncology service (see 3.3.2 below). Notably, according to the cilta-cel Risk Evaluation and Mitigation Strategies (REMS), a minimum of two doses of tocilizumab must be available for each patient for infusion within 2 hours after cilta-cel infusion, if needed, for treatment of CRS. Thus, admission protocols should account for the administration of tocilizumab in the ED, where appropriate.

Critical success factor: establish multidisciplinary professional training

The cilta-cel outpatient program team should be multidisciplinary and include consults from infectious disease, the intensive care unit, neurology, and other departments. Each site should identify all involved team members, including nurse coordinators or navigators, pharmacists, dietitians, and medical social workers, and ensure that all are adequately trained. Access to other consultative services, such as neurology, may be helpful to clinicians managing neurologic AEs post-treatment.

From a professional training standpoint, outpatient cilta-cel programs are comparable to outpatient transplant programs. In general, staff from centers with experience managing outpatient transplant programs will have the clinical experience and capabilities to administer outpatient CAR-T therapy. Centers unfamiliar with outpatient transplants are encouraged to gain experience by managing patients receiving CAR-T therapy in the inpatient setting before implementing an outpatient program.

Critical success factor: identify exceptions to outpatient treatment and monitoring

For cilta-cel outpatient administration programs, all patients who meet the criteria for cilta-cel eligibility may be considered eligible for outpatient therapy. Planned admissions are not required for patients receiving cilta-cel in the outpatient setting. Thus, each institution may draft criteria to identify those patients who are the exception and who require inpatient treatment and monitoring. Due to logistical challenges in coordinating care, patients requiring dialysis usually receive cilta-cel therapy as inpatients at this time, unless the center can offer a seamless transition of dialysis care. In addition, the presence of rapidly progressing disease, any condition that significantly impacts performance status or requires closer monitoring (eg, amyloidosis), impaired mobility, or any other comorbidity that would impair the patient from tolerating higher grade CRS in the outpatient setting, may be cause for considering inpatient administration. Any comorbidity preventing the patient from tolerating CRS would prompt me to administer inpatient. Dr Pantin

Depending on patient needs and institutional infrastructure, other considerations for inpatient administration may include limited or unreliable access to social support for the patient, high burden of disease, significant extramedullary disease, or development of new comorbidities (eg, progressive renal failure, new fracture limiting mobility) at the time of lymphodepletion. In a study of 43 patients with relapsed/refractory MM, 4 patients were hospitalized and treated inpatient due to MM-related conditions, including 1 for chemotherapy-related gastrointestinal toxicity and 1 for patient preference [ 9 ]. Other reasons for consideration of inpatient treatment may include, but are not limited to, a history of grade ≥ 3 CRS or ICANS with prior CAR-T therapy, home oxygen requirement, lack of adequate organ function, or active central nervous system disease [ 25 ].

One roundtable participant noted an exception is made for patients without access to full caregiver support. In these cases, based on the delayed CRS profile expected with cilta-cel, a planned admission on day 5 after infusion may be considered, as well as admission for the duration of treatment. This is based on outcomes from the CARTITUDE-1 and CARTITUDE-4 trials, where the median time to onset of CRS (7–8 days) and ICANS (8–9.5 days) was after 1 week ( Table 2 ) [ 15 , 18 ]. Table 2. CRS and ICANS time to onset and duration in CARTITUDE-1 and CARTITUDE-4. Event CARTITUDE-1[ 18 ] ( N = 97) CARTITUDE-4[ 15 ] ( N = 176) CRS, median time to onset from cilta-cell infusion, days 7 (IQR: 5–8) 8 (range: 1–23) CRS, median duration, days 4 (IQR: 3–6 a ) 3 (range: 1–17) ICANS, median time to onset from cilta-cel infusion, days 8 (IQR: 6–8) 9.5 (range: 6–15) ICANS, median duration, days 4 (IQR: 3–6.5) 2 (range: 1–6) a Excluding one patient with a 97-day duration. Cilta-cel, ciltacabtagene-autoleucel; CRS, cytokine release syndrome; ICANS, immune effector-cell associated neurotoxicity syndrome; IQR, interquartile range.

Critical success factor: identify AEs to be managed in the inpatient vs the outpatient setting

Roundtable participants estimated that up to 50% of their patients treated with cilta-cel in the outpatient setting may not require hospitalization for AE management. For individuals requiring hospitalization, day 5 was the estimated average day of admission (range: 3–7+), with the average duration of admission being 4.2 days (range: 3–5). My feeling is, if you want to administer CAR-T outpatient, you should be able to manage low-grade CRS outpatient. Dr Dhakal

With no planned admissions, institutions may identify which expected AEs will be treated outpatient and which will trigger admission for treatment. According to roundtable participants, cytopenias and grade 1 CRS can generally be managed in the outpatient setting with the appropriate resources, unless fever occurs in the setting of neutropenia, in which case the risk of sepsis should be weighed against the benefit of outpatient management. Patients with grade 2 or higher CRS or any grade ICANS are typically admitted. Participants reported that persistent fever, after initial management in the outpatient setting, is generally the most common reason for admission. Other reasons for admission include immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome, rapid increase in ferritin levels, and neutropenic fever [ 26 ].

Critical success factor: implement patient and caregiver education programs

Ensuring that both patients and caregivers understand the treatment, the instructions for care, and their overall responsibilities is critical to the success of therapy. Each site could develop a patient/caregiver education program unique to their clinic. One example of a successful patient/caregiver education initiative at an outpatient program is having a dedicated myeloma CAR-T coordinator who meets with patients and caregivers for an hour before they meet with the physician, ensuring the patient and caregiver understand the program. Another outpatient program provides live educational classes, printed materials, and a contract outlining patient and caregiver responsibilities that both parties must sign.

Attendance at educational programming by both patients and caregivers should be required to move forward with treatment. Offering live and virtual options for educational sessions, as well as some 1:1 education time, may be helpful. As always, patient preference is important and should be part of any patient/health care provider discussion.

Critical success factor: establish avenues for patient financial assistance

The challenges of insurance coverage and housing are real. Dr Huff

Even with insurance coverage, the treatment period can put a significant financial burden on families, including medical costs, lost wages for the patient and potentially the caregiver, and possibly the need for local lodging and transportation. Verifying patients have appropriate insurance coverage, as well as assisting patients with having general financial support in place, will help ensure the outpatient program is sustainable. Individual clinics may have access to financial assistance programs, such as local lodging programs or grants, that can be offered to patients (see 3.2.2 below). In addition, financial assistance may be available through patient support programs at individual pharmaceutical companies.

Patient factors critical to the success of an outpatient cilta-cel program

Critical success factor: access to 24/7 committed caregiver support

Critical to patient success is the support of a caregiver, 24 hours per day, 7 days per week. This role may be filled by one person or by multiple people, but, if possible, each caregiver should make a 1-week commitment for continuity of care. An appropriate caregiver is an adult, reliable, familiar to the patient, invested in the patient’s health outcomes, and understands their role and responsibilities as a caregiver. It is very helpful if the caregiver does not have significant personal health issues that might interfere with their responsibilities and does have access to reliable transportation.

Critical success factor: access to reliable transportation and local lodging

I don’t think the financial burden can be underestimated for the patients. Dr Janakiram

Patients must have reliable transportation to and from the treatment center. In addition, patients who do not live close to their treatment clinic must secure local lodging for the duration of therapy and monitoring. Individual clinics may have access to financial assistance programs, such as local lodging programs or grants, that can be offered to patients. In addition, financial assistance may be available through patient support programs at individual pharmaceutical companies (see 3.1.6 above).

Critical success factor: honoring patient preference and supporting patient quality of life

As with any patient-centered program, honoring patient preferences and working to support patient quality of life are critical to overall success. Understanding how patients value different treatment characteristics, such as efficacy and safety profiles, as well as how patients value different potential outcomes, such as extending patient life and improving patient quality of life, may contribute to outpatient program success [ 27–29 ].

Additional considerations for establishing an outpatient cilta-cel administration program

Although not critical, some considerations may be helpful to the success of an outpatient program if they are feasible at an individual institution or clinic.

Additional considerations: remote patient monitoring

Caregivers see more things rather than miss things. They see the patient every day, so they notice when something is off. Dr Alsina

Most steering committee participants ask caregivers to track patient symptoms and medications at home via questionnaires and paper forms. One participant reported using digital remote monitoring at their clinic, and participants opined it was a “nice-to-have” but not a requirement. Notably, some steering committee members feel that caregivers know the patient well and often notice changes and bring them to the attention of the clinical team. With remote monitoring, the patient and caregiver utilize technology that provides continuous (24/7) monitoring of specific patient vital signs. The device sends the data to a central location, which is monitored by staff. Any concerning changes in data trends trigger a staff member to call the patient and caregiver to check the patient’s oral temperature and pulse. This form of monitoring may be particularly useful if the caregiver is elderly and finds it difficult to keep up with constant patient monitoring. As outpatient programs are more widely adopted and technology improved and updated, the availability of digital tools may improve safety and accessibility in some populations [ 30 ].

One reason our clinic initiated remote monitoring is many patients are elderly and their caregivers are elderly and are too frail to keep up with at-home monitoring.

Additional considerations: admission through an oncology-specific “urgent care” (ie, a 24/7 oncology clinic)

While it is preferable to admit patients through an oncology-only “urgent care” clinic, admitting patients through the ED is a safe alternative as long as there is open communication between the ED and the hematology/oncology service (see 3.1.1 above).

Additional considerations: metrics tracking for program long-term improvement

Once a program has been established, specific metrics can be tracked to ensure continual and long-term improvement. Daily toxicity assessment through day 10 post-infusion, rate of CRS, rate of ICANS, infection rate, any non-hematologic grade 3/4 AEs, and day 30 response, among other parameters, may be considered for metric tracking.

Discussion

This article is the culmination of five hematology/oncology experts with clinical experience with outpatient cilta-cel administration programs meeting to identify key success factors for establishing a similar outpatient program. Similar to our experience, Furqan et al reported on the feasibility of outpatient administration of CAR-T therapies without remote monitoring but with early CRS intervention. Among 58 patients who received outpatient CAR-T for a hematologic malignancy, hospitalization was prevented in 43% (15/35) of patients who received tocilizumab for CRS as an outpatient [ 31 ]. In addition, Hamza et al demonstrated shortened hospitalization times for patients with MM receiving CAR-T therapy in the outpatient setting vs in the inpatient setting [ 9 ].

Patients should have access to a dedicated CAR-T-experienced health care professional 24 hours per day, 7 days per week, as well as 24-hour access to a dedicated hospital bed. While the clinical staff may remain small, a multidisciplinary approach is encouraged, including professional training to support the entire team. The contribution of multidisciplinary teams to the success of outpatient programs has been shown across hematologic disease states, including in B-cell lymphoma [ 4 ].

Each institution should consider drafting criteria to identify patients who are the exception to outpatient therapy and who require inpatient treatment and monitoring. The 2024 American Society for Transplantation and Cellular Therapy expert panel on CAR-T therapy outlined several clinical and logistical aspects to consider, but each treatment center and physician group will need to identify those criteria most relevant to their setting [ 6 , 25 ]. In addition, institutions should consider identifying which treatment-related expected AEs will be treated in the outpatient setting and which will trigger admission. The relatively delayed time to onset of CRS and ICANS with cilta-cel compared to other therapies, such as idecabtagene vicleucel, supports this approach [ 15 , 18–20 ]. Published literature to date does not suggest any new or increased safety signals with cilta-cel administration in the outpatient setting [ 6 ].

From the patient perspective, access to a consistent and supportive caregiver 24 hours per day, 7 days per week, is critical. Patients must also have reliable transportation to and from their treatment center and secure local lodging if they do not live near their treatment center. Other studies have reported that patients who successfully navigated outpatient programs lived within 45 minutes of the hospital, utilized an on-campus hospital guest house, resided in a hotel, or stayed with family in the area [ 31 ]. Each institution should consider how it can contribute to establishing avenues for supporting patient preference and quality of life, as well as patient financial assistance [ 27–29 ].

Conclusions

To start an outpatient CAR-T program, they must have the infrastructure and staff must have experience identifying and managing CRS and ICANS. Dr Alsina

Outpatient administration of CAR-T therapy for the treatment of MM can be feasible and safe when institutions implement the infrastructure, policies, and procedures necessary to appropriately support and manage this patient population. Several successful outpatient administration programs utilizing cilta-cel have been established throughout the US. This has been driven both by unmet needs (reduced hospital resource utilization and financial burdens) and by opportunities (cilta-cel used earlier in the treatment journey and the cilta-cel safety profile having clearly defined delayed onset of CRS and ICANS events). As more sites adopt outpatient cilta-cel programs, institutions may benefit from decreased hospital bed usage, shorter hospital stays, and lower costs, all while maintaining safety and efficacy for patients. Patients may benefit from shorter hospital stays and reduced financial burdens. Institutions that wish to start an outpatient administration program using cilta-cel can begin by utilizing resources already in place, identifying remaining infrastructure needs, and ensuring protocols are developed to optimize outcomes. Additional findings from real-world experience with cilta-cel therapy administered in the outpatient setting may improve outpatient policies and procedures and help to provide cilta-cel and other transformative therapies to many more patients.

Supplementary Material

Supplemental Material

Acknowledgments

The authors thank Matthew Perciavalle, PharmD; Victoria Alegria, NP; and Vrinda Mahajan, PharmD, for organizing and contributing to the roundtable discussion topics highlighted in this review. Medical writing and editorial assistance were provided by R&R Healthcare Communications.

Article highlights

Outpatient Cilta-cel Program: Success Factors Critical Institutional Factors

Ensure adequate staffing and access to hospital beds for 24/7 patient monitoring and care. Establish multidisciplinary training and protocols to effectively manage expected adverse events in the outpatient setting is essential. Implement robust patient and caregiver education programs, along with helping patients secure financial assistance.

Critical Patient Factors

Access to a committed 24/7 caregiver. Reliable transportation and be able to secure local lodging if patients do not live near the treatment center. Honor patient preference and support patient quality of life.

Additional Considerations

Implement remote patient monitoring systems and developing an oncology-specific “urgent care” for patient admissions may enhance outpatient programs. Track key metrics can drive continuous improvement of the outpatient program over time.

Declaration of interest

M Alsina reports research support from Bristol Myers Squibb and membership on the Board of Directors or advisory committees for Bristol Myers Squibb, Janssen Pharmaceuticals and Sanofi. B Dhakal reports research support from Bristol Myers Squibb, Janssen Pharmaceuticals, Arcellx, Kite Pharma, CARsgen, Sanofi, Gracell and C4 Therapeutics and membership on advisory boards for Sanofi, Bristol Myers Squibb, Janssen Pharmaceuticals, Arcellx, Karyopharm, Genentech and Pfizer. CA Huff reports research support from Prothena Biosciences and Ichnos Sciences and membership on advisory boards of Sanofi, Legend Biotech and Janssen Pharmaceuticals. J Pantin reports speaker’s bureau work for Sanofi, Bristol Myers Squibb and Omeros Corporation and honoraria and consultancy from Legend Biotech and Novartis Pharmaceuticals. M Janakiram reports research funding from Janssen Pharmaceuticals, Bristol Myers Squibb and Fate Therapeutics and membership on advisory boards of Legend Biotech, Bristol Myers Squibb and Janssen Pharmaceuticals.

Author contributions

All authors (Melissa Alsina, Binod Dhakal, Jeremy Pantin, Carol A. Huff, Murali Janakiram) completed the following author contribution tasks: Made a significant contribution to the work reported, whether that’s in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas. Have drafted or written, or substantially revised or critically reviewed the article. Have agreed on the journal to which the article will be submitted. Reviewed and agreed on all versions of the article before submission, during revision, the final version accepted for publication, and any significant changes introduced at the proofing stage. Agree to take responsibility and be accountable for the contents of the article and to share responsibility to resolve any questions raised about the accuracy or integrity of the published work.

Ethical Declaration

Ethical approval was not needed for this manuscript as no study was conducted, no patients were involved or identified, and no patient consent was required.

Data availability statement

The authors confirm that the data supporting the findings of this study are available within the article and its supplementary materials.

Writing disclosure

Medical writing and editorial support was provided by Mary L. Smith, PhD, CMPP, and Java Solis of R&R Healthcare Communications, and was funded by Janssen Pharmaceuticals, Inc, and Legend Biotech USA Inc.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14796694.2025.2476382

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