Tabelecleucel in Post-transplant Epstein-Barr Virus-Associated Lymphoproliferative Disease: Patient and Oncologist Perspectives.

Key Summary Points

Introduction

This article presents the perspective of a patient and her family during a complex medical journey, marked by a lifesaving multi-visceral transplant and subsequent experimental treatment for Epstein–Barr virus (EBV)-associated post-transplant lymphoproliferative disease (EBV + PTLD). Paula, a Spanish teenager, faced a rare and severe disease trajectory, and her experience highlights the challenges and resilience encountered throughout.

Ethics committee approval and informed consent were not required for this publication, as it does not involve a clinical trial or observational study. This is a narrative case report shared from the perspective of the patient’s parents and the treating specialist.

Patient and Caregivers’ Perspectives

‘My name is Paula. I’m 14 years old. I enjoy recording TikTok videos, skating, and riding my bike. When I was told I would be receiving lymphocytes to help me get better, I felt a bit nervous at first, but everything turned out fine. I had been feeling weak for a while, but now I have regained my strength.’ Paula is just another teenager. She holds her mobile phone, smiles, is discreet, and is polite. She knows how to be throughout the entire interview.

Paula’s parents exude warmth and optimism—qualities often seen in those who have witnessed their child recover from life-threatening illness. They explained that Paula was a healthy child at birth. However, at her two-year check-up with her regular pediatrician, abdominal lumps were detected, which were later diagnosed as ganglioneuroblastoma.

The patient was transferred from her home province (Zamora, Spain) to the Hospital Clínico Universitario de Salamanca (Salamanca, Spain), where further evaluation led to a recommendation for surgical intervention at the Hospital General Universitario de Valencia (Valencia, Spain). Postoperatively, she developed multiple thrombi affecting the liver, pancreas, spleen, and intestines. Additionally, esophageal varices emerged, resulting in episodes of hematemesis.

These complications caused progressive multi-organ deterioration, with the liver being particularly affected. Consequently, at the age of 12, the patient underwent a multi-visceral transplant at the Hospital Universitario La Paz (Madrid, Spain). Her parents recall being fortunate, as a compatible deceased donor was found within six months despite the pandemic. With a suitcase permanently packed and ready, they traveled the two-hour journey to Madrid to face the challenge. The transplant surgery was lengthy and complex, but they firmly believed that ‘ with Paula, the medical team fought .’ The surgeons reassured them before entering the operating room: ‘We are going to take care of your daughter ’. Additionally, the Spanish Association for the Support of Patients with Intestinal Failure, Parenteral Nutrition, and Multi-visceral Transplantation (NUPA) accompanied Paula’s parents throughout the 15-h procedure. The medical team provided regular updates, and Paula’s mother appreciated that the staff remained compassionate throughout. Suddenly, one gastroenterology team member came out dancing: the surgery was completed successfully.

Paula’s family placed full trust in the medical professionals and supported every hospital transfer across the country. They share that they always ‘ thought with their eyes closed, forwards ’. Paula, curious and engaged, was kept informed at every step. ‘ After spending a month and a half in the ICU, Paula lost the ability to walk. Still, whenever she could, we carried her outdoors, even if it was just for ten minutes. ’

Transplant recipients, who are inherently immunosuppressed, are at an increased risk of developing malignancies, with PTLD being the most common in pediatric patients. PTLD typically arises in the context of primary EBV infection or reactivation, as was the case for Paula. Twenty-one days after hospital discharge following the transplant, she presented with fever, elevated EBV viral load in peripheral blood, and a hepatic mass detected by abdominal ultrasound. Further diagnostic evaluation confirmed the diagnosis of PTLD.

Chemotherapy consisted of R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). However, Paula experienced severe complications, including mucositis, pancytopenia, and meningitis. Following two cycles of treatment, no clinical response was observed. Treatment options are limited for patients who fail rituximab with or without chemotherapy. Recent real-world data indicate that the prognosis for patients with relapsed or refractory (R/R) EBV + PTLD following hematopoietic stem cell transplantation (HSCT) remains poor [ 1 ].

‘ The chemotherapy made her feel really sick ,’ says her mother, who shaved her hair in solidarity. After completing more than half of the chemotherapy cycles, the treatment was discontinued due to meningitis. The disease remained aggressive and both lymphoma and EBV persisted. With no remaining standard therapies and Paula suffering from severe respiratory and multiorgan failure, her life expectancy was reduced to weeks.

The medical team informed the parents that Paula had limited time but that they would continue exploring new therapeutic options, including hematopoietic and cellular therapies. They asked if the family would consider an experimental treatment with minimal precedent. ‘Paula was in very bad shape, and the doctors decided to try a lymphocyte transplant, so we had doubts about how her body would react’, says her mother.

Without hesitation, the family agreed—’ it was the only window we could see,’ they said. Paula received ‘ some lymphocytes that came from America’ . As they were infused, they noticed a strong smell of cockles and Paula began improving almost immediately. She received two cycles of treatment, each comprising intravenous tabelecleucel administered at a dose ranging from 1.6 × 10⁶ to 2.0 × 10⁶ cells per kilogram on days 1, 8, and 15, without preceding lymphodepleting therapy. Treatment response was assessed by PET/CT between days 28 and 35 of each cycle. A maximal response was achieved after two consecutive cycles, resulting in a complete remission (CR).

Throughout this arduous journey, Paula’s parents consistently felt supported and well-informed by the medical teams involved. They also acknowledge the strong coordination between different hospitals and specialties, which encouraged them to follow all medical guidance. The NUPA association played an essential role by offering emotional support and temporary housing in Madrid. Their experience at NUPA provided them with a sense of belonging and a home away from home.

Today, Paula attends secondary school and dreams of becoming an interior decorator. She enjoys the swimming pool in the summer and her village festivals and her appetite has returned. She travels to Madrid every three months for follow-up at the Intestinal Rehabilitation and Transplant Unit, where evaluations are performed to ensure optimal graft function and appropriate nutritional status. Additionally, she is seen by the Hemato-Oncology team, who monitor for any signs of recurrence of the lymphoproliferative disorder. The hospital helps coordinate her appointments on the same day so that Paula does not miss minimal school and time with her siblings. ‘ Paula has not told her classmates about any of this. She just does gymnastics with them like nothing happened.’

Her mother is surprised that Paula no longer needs anti-rejection medication to avoid. Her only remaining issues are mild discomfort from dry eyes and trichiasis, which are expected to be resolved soon.

‘Paula has changed tremendously. She now runs, rides her bike, swims, and never misses a day of school. She wakes up each morning full of energy and joy. We are deeply grateful for this treatment–without it, our daughter would not be here today. She has returned to her normal life. It has been a truly transformative experience.’

Oncologist’s Perspective

Health Issues and Tabelecleucel

PTLD is a complication of immunosuppressive therapy, defined as a lymphoid neoplasm arising after allogeneic HSCT or solid organ transplantation (SOT). Transplant recipients face a heightened risk of neoplasms associated with immunosuppression and EBV, particularly lymphomas [ 2 , 3 ].

EBV-positive PTLD represents approximately 21% of all neoplasms in SOT recipients. Its incidence has increased over the past two decades, driven by a growing number of transplants, older donor and recipient populations, the use of novel immunosuppressants, the adoption of haploidentical HSCT, and improved diagnostic capabilities [ 4 , 5 ]. The standardized incidence rate of PTLD in transplant recipients in SOT is estimated at 10% for non-Hodgkin’s lymphoma, 4% for Hodgkin’s lymphoma, and 3.2% for those who undergo HSCT, although this varies depending on donor type [ 2 ].

In SOT recipients, PTLD follows a bimodal incidence pattern, with an early peak within the first 12 months post-transplant and a later peak between 5 and 15 years [ 6 – 8 ]. Clinical manifestations are heterogeneous, ranging from asymptomatic incidental findings to aggressive presentations. Extra nodal involvement is common and may include the gastrointestinal tract (20–30%), transplanted organs (10–15%), and central nervous system (5–20%) [ 8 – 10 ].

The clinical burden of EBV + PTLD is substantial, with high mortality rates and short survival in patients who fail first-line therapies. Mortality rates exceed 30% and can reach up to 80% within one year in some reports. Median overall survival (OS) ranges from just 0.7 months after HSCT to 4.1 months after SOT [ 11 ]. The condition also imposes a significant economic burden and demands extensive healthcare resources. Consequently, there is an urgent need for effective and low-toxicity treatment options for patients with R/R EBV + PTLD [ 12 ].

Tabelecleucel is an allogeneic, off-the-shelf, EBV-specific T-cell immunotherapy. It received conditional approval from the European Medicines Agency in 2022 as a monotherapy for adult and pediatric patients (≥ 2 years old) with R/R EBV + PTLD who have received at least one prior therapy (including chemotherapy in the case of SOT, unless contraindicated) [ 13 ]. Tabelecleucel is the first therapy of its kind approved for this indication.

Experience in the Evolution of the Case Report

Dr. Pérez, currently part of the bone marrow transplantation team at Hospital Universitario La Paz (Madrid, Spain), is also responsible for managing post-transplant hematological complications. He explains: ‘ PTLD is relatively common and is typically managed by discontinuing immunosuppression or administering rituximab, a monoclonal antibody that targets B lymphocytes—the primary reservoir for EBV . While this approach is effective in approximately two-thirds of cases, there remains a subset of patients in whom rituximab fails to fully eliminate B cells or in whom EBV infects other cell types, such as T lymphocytes. ’

‘Rituximab-refractory PTLD presents a major therapeutic challenge. In these cases, chemotherapy is often the only remaining option, despite its high toxicity and limited efficacy in already fragile patients. Unfortunately, the prognosis is usually poor, and the disease is considerably incurable in such scenarios. Tabelecleucel offers a novel therapeutic approach for these vulnerable patients.’

Paula received basiliximab as induction therapy for the multivisceral transplant, followed by maintenance immunosuppression with steroids and tacrolimus, which she was still receiving at the time the complication developed. ‘In the case of our patient [ 14 ] , once the diagnosis of EBV + PTLD was confirmed, her care team recognized that continuing immunosuppressive therapy would likely worsen her condition, potentially leading to uncontrolled lymphoma. Deciding to withdraw immunosuppressants was a significant challenge’ , Dr. Perez recalls . ‘We had to carefully weigh the risks of uncontrolled malignancy against the risk of graft rejection. For patients who are refractory to both to rituximab and chemotherapy, tabelecleucel may be considered after immunosuppression has been discontinued. While this strategy results in disease control in approximately two-thirds of patients, immunosuppression often needs to be reintroduced to prevent graft rejection. In most SOT cases, complete and permanent withdrawal of immunosuppressive drugs is not possible.’

However, Paula’s case turned out to be exceptional. Three years later, at the time of this writing, she remains off immunosuppressive therapy. ‘ This young girl underwent a multi-visceral transplant (including pancreas, stomach, gut, and liver) from a fully major histocompatibility complex-mismatch deceased donor.’ Intestinal-containing grafts present particular management challenges due to their high immunogenicity, largely attributed to the abundance of lymphoid tissue. Although the graft also included a liver—an organ known to exert a protective immunomodulatory effect—the risk of rejection remains significantly elevated. ‘ To our knowledge, this is the first documented case worldwide where a patient has not only recovered from EBV + PTLD resistant to rituximab and chemotherapy but also developed immunological tolerance—allowing her to live without ongoing immunosuppressive treatment. The underlying biological mechanism of this immune tolerance remains unknown, but the clinical outcome is extraordinary. ’

Tabelecleucel Access

Access to drugs and other medical supplies is a key component of the right to health. Under Spanish legislation, investigational drugs can be provided to individual patients who are not eligible for clinical trials, lack a satisfactory therapeutic alternative, and are in a clinical condition that precludes waiting for standard regulatory approval processes to conclude [ 15 ] .

Dr. Perez recalls: ‘At the time, the clinical trial involving tabelecleucel (NCT03392142) was not being conducted at our hospital, and enrolment had already closed at other participating centers.’ Despite these limitations , the Pediatric Hemato-Oncology and Hematopoietic Transplantation Department proactively contacted the trial sponsor . ‘ Although the recruitment period had ended, we managed to reach the medical director, who referred us to a contact in New York. After we explained the urgency of the situation, they agreed to provide through a compassionate use program. This authorization was granted under an exceptional use protocol, allowing Paula to receive the therapy outside the clinical trial framework without affecting the trial’s sample size or database integrity. Thanks to our team’s persistence and determination, access to tabelecleucel was made possible—without any cost to the hospital.’

‘From a logistic standpoint, tabelecleucel is straightforward to administer. It is supplied in a ready-to-use format and only requires preparation in a laminar flow cabinet. It imposes no additional technical burden on the hospital.’

However, cost remains a significant concern. ‘ This therapy is expensive, and hospital pharmacies often argue that marketed alternatives are available. Nonetheless, in cases where those alternatives fail, it’s imperative to consider the potential value of tabelecleucel. ’

He emphasized the need for future cost-effectiveness studies to compare outcomes with standard-of-care treatments and justify broader implementation in the healthcare system.

Future Research: Immunomodulation

Dr. Perez emphasized that ‘in Paula’s case, tabelecleucel appears to have played a role beyond EBV-targeted immunotherapy. It may have modulated the allogeneic immune response, enabling long-term tolerance of a multi-visceral graft without ongoing pharmacological immunosuppression. This is particularly significant in the field of SOT.’

Intestinal transplantation, and to a lesser extent multi-visceral transplantation, are highly immunogenic procedures that necessitate intense immunosuppressive regimens. These are frequently associated with complications such as viral reactivation, PTLD, and elevated rates of rejection. The induction of immunological tolerance represents a key objective in overcoming these limitations. Tolerance mechanisms, potentially mediated by donor alloreactive T cells through both central (thymic) and peripheral (lymph node) pathways, may arise spontaneously following intestinal or multi-visceral transplantation. Although the precise mechanisms remain poorly understood, in our patient, tolerance is likely mediated by micro- or macrochimerism following haploidentical memory donor lymphocyte infusion and/or the presence of hematopoietic progenitor cells within the multi-visceral graft. These immunological phenomena have been associated with reduced rates of rejection and may reflect potent graft-versus-host immune modulation [ 16 ].

Besides, ‘thymic function in pediatric patients might allow for greater immune plasticity compared to adults. Children have more adaptable biological systems, and this immune flexibility may favor the development of tolerance mechanisms. Exploring how tabelecleucel might contribute to such immunomodulatory effects represents a promising research field.’

Dr. Pérez has advocated for the establishment of specialized units dedicated to immune-mediated diseases encompassing infections, cancer, and autoimmunity, among others : ‘Many conditions arise from immune dysregulation. If we can modulate the immune system, rather than just suppress it, we may open new therapeutic pathways. This represents a shift toward 21st-century medicine—not to replace pharmacology, but to complement it.’

‘Classical pharmacological models do not apply to living-cell therapies. Regulatory bodies must develop new assessment paradigms involving experts in medicine, biology, and chemistry to evaluate disruptive technologies such as these.’

Dr. Perez concluded this section by reaffirming the clinical uniqueness of Paula’s case: ‘This is an exceptional report. While it may not be replicable on a large scale, the clinical evidence is strong enough to warrant serious consideration and further investigation.’

Multidisciplinary Team Approach

The successful management of this complex case was made possible by the involvement of a highly coordinated multidisciplinary team. Each clinical specialty contributed its expertise at different stages of the patient’s journey, from transplantation to post-treatment recovery.

Following the multi-visceral transplant performed by the Pediatric Surgery Unit, the patient was closely monitored by the Intestinal Rehabilitation Team from the Pediatric Digestive Unit. This team managed the delicate balance of nutritional and gastrointestinal support, crucial during the early post-transplant phase.

Upon diagnosis of EBV + PTLD, the patient was referred to the Pediatric Hemato-Oncology and Hematopoietic Transplant Unit, where the therapeutic strategy was defined. This included the administration of tabelecleucel after the failure of first-line treatments.

The Clinical Pharmacology Unit supervised the immunosuppressive regimen, making necessary adjustments to minimize toxicity while maintaining graft viability.

Throughout the entire process, nursing staff provided essential day-to-day care. Their close involvement ensured continuity of care and contributed significantly to the patient’s overall well-being and adherence to treatment protocols.

This case exemplifies the importance of a coordinated, multidisciplinary approach in managing complex post-transplant complications, and highlights the value of collaborative expertise in implementing innovative therapies such as tabelecleucel.

The Potential of Tabelecleucel in Other Pathologies

Dr. Pérez emphasized that tabelecleucel targets conditions involving uncontrolled proliferation of EBV-infected cells. While EBV is typically a latent virus existing within the host, immunosuppression can impair T-cell function, allowing viral reactivation and proliferation. This is the context in which tabelecleucel has demonstrated the greatest potential .

The success of tabelecleucel in EBV + PTLD has prompted exploration into its application in other EBV-related malignancies, such as nasopharyngeal carcinoma. However, clinical trials in this area have so far yielded limited results, likely due to the complex pathogenesis of epithelial tumors, which often involves mechanisms beyond EBV alone. Therefore, Dr. Pérez suggests that tabelecleucel might also offer good outcomes when used in combination with other therapeutic strategies .

He further noted that the cytotoxic T-cell lymphocytes platform underlying tabelecleucel could be adapted to target other viruses, such as cytomegalovirus or adenovirus. This concept opens the door to personalized, virus-specific immunotherapies across a range of immune-mediated disorders.

Dr. Pérez also highlighted parallels with other immunotherapeutic platforms such as chimeric antigen receptor T-cell therapy. This was originally developed for HIV and chronic lymphocytic leukemia and is now being investigated for a broader spectrum of conditions, such as B-cell acute lymphoblastic leukemia, B-cell lymphoma, and multiple myeloma or immune-mediated diseases like systemic lupus erythematosus or dermatomyositis ( 17 ) .

In conclusion, while tabelecleucel is currently approved for EBV + PTLD, its therapeutic framework may serve as a foundation for future immunotherapies targeting EBV-mediated cancers, such as nasopharyngeal cancer, gastric carcinoma, and leiomyosarcoma. It could also be explored for broader applications in immune oncology, especially through combination regimens guided by collaborative research between academia and the pharmaceutical industry.

Lessons and Strategies for Future Collaboration

Dr. Pérez concludes by emphasizing that ‘Paula is the true protagonist of this case’. He describes her recovery as a testament to the transformative power of science. In his words, ‘the miracle, in this case, is called science’.

Reflecting on the communication format of this article, he highlighted the importance of incorporating the patient’s voice, particularly in cases like Paula’s, where palliative care was once the only option. ‘This format allows patients and families to share their experiences’ , he said.

Dr. Pérez advocates for a new model of collaboration—centered around the patient—that brings together researchers, clinicians, industry stakeholders, and health systems. He argues that this synergistic approach can accelerate the development of treatments for unmet medical needs and foster innovation in complex, rare, or immune-mediated diseases.

According to Dr. Pérez, these partnerships represent a ‘win–win scenario’ for all involved: patients receive more effective treatments, researchers gain real-world insights, and health systems benefit from more efficient, personalized approaches to care.

‘This case' , he concludes, 'represents not only a unique and disruptive clinical event but also a roadmap for how collaborative, patient-focused science can transform the future of medicine.'

Acknowledgments

Medical Writing/Editorial Assistance

We would like to thank María Romero who wrote the outline and first draft of this manuscript on behalf of Springer Healthcare. This medical writing assistance was funded by Pierre Fabre.

Author Contributions

Antonio Pérez Martínez, Anarbella Lastra Rodrigo, Esther Ramos Boluda, Berta González Martinez, Alida Alcolea Sánchez and Francisco Hernandez Oliveros contributed to the conception and provided critical feedback on the manuscript. All authors approved the final article.

Funding

The medical writing assistance and the journal’s rapid service and open access fee was supported by Pierre Fabre, who did not influence any aspect of the study design, data collection, analysis, or interpretation, or the decision to submit the manuscript for publication.

Data Availability

Data sharing is not applicable to this article as no datasets were generated or analysed during the current study.

Declarations

Conflict of Interest

Antonio Pérez Martínez, Anarbella Lastra Rodrigo, Esther Ramos Boluda, Berta González Martinez, Alida Alcolea Sánchez and Francisco Hernandez Oliveros declare that they have nothing to disclose.

Ethical Approval and Consent to Participate

Participants were informed about the objectives of the study, and written informed consent for publication was obtained before the article was drafted. All authors approved the final manuscript.

Footnotes

Prior Publication : Some content from this manuscript was previously published in a manuscript titled ‘Familiar CD45RA⁻ T Cells to Treat Severe Refractory Infections in Immunocompromised Patients’ AlAkioui Sanz K, Echecopar Parente C, Ferreras C, Menéndez Ribes M, Navarro A, Mestre C, Clares L, Vicario JL, Balas A, De Paz R, López Granados E, Sánchez Zapardiel E, Jiménez C, López-Oliva M, Ramos E, Hernández-Oliveros F, Pérez-Martínez A. Familial CD45RA T cells to treat severe refractory infections in immunocompromised patients. Front Med (Lausanne). 2023 Feb 8;10:1083215. doi: 10.3389/fmed.2023.1083215. PMID: 36844219; PMCID: PMC9944023.

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Associated Data

Data Availability Statement

Data sharing is not applicable to this article as no datasets were generated or analysed during the current study.