Hematology, transfusion and cell therapy · 2026
Process Characterization and Determinants of CD3⁺ Cell Yield During Autologous Leukapheresis for CAR-T Cell Manufacturing: A Single-Centre Experience from Western India.
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Desai Priti, Navkudkar Anisha, Suresh Aswathi, Sengar Manju, Jain Hasmukh, Bagal Bhausaheb, Nayak Lingaraj, Shetty Alok, Purwar Rahul, Karulkar Atharva, Kalra Devanshi, Ravikumar Smriti, Tembhare Prashant
Аннотация
BACKGROUND: Chimeric Antigen Receptor T-cell (CAR T-cell) therapy is a promising treatment option for patients with refractory or relapsed B-cell malignancies. The success of this therapy depends on the efficient collection of lymphocytes (CD3+ T cells) through apheresis. This study analyzed the factors influencing CD3+ cell counts in apheresis products for CAR T-cell therapy.
METHODS: This exploratory analysis evaluated patients enrolled in the registration phase I/II trials of talicabtagene autoleucel at a tertiary care oncology centre in Western India. Patients were enrolled after obtaining informed consent. The study was approved by the Institutional Ethics Committee and the Central Drugs Standard Control Organisation (CDSCO), and registered with the Clinical Trials Registry of India. A total of 48 autologous lymphocytapheresis procedures were performed on 44 patients with refractory or relapsed lymphoma (predominantly diffuse large B-cell lymphoma) or B-acute lymphoblastic leukemia. Pre-apheresis hematological parameters and flow cytometry were used to estimate absolute lymphocyte counts and peripheral blood CD3+ cell counts. Predictive factors for CD3+ cells in the product were analyzed using the Pearson correlation coefficient and regression models by the Statistical Package for Social Sciences software (Version 25.0, Armonk, NY: IBM Corp.), and p-values <0.05 were considered statistically significant.
RESULTS: Pre-apheresis parameters like total leukocyte count, absolute lymphocyte count, and circulating CD3⁺ cell count were all positively correlated with the absolute CD3+ cell yield in the apheresis product (p < 0.05). Importantly, these associations remained significant in multivariate analysis, highlighting their independent predictive value for the harvested CD3+ count. Additionally, lower pre-apheresis hematocrit and higher platelet levels were independently associated with reduced CD3+ recovery. Notably, the targeted CD3+ cell dose was successfully achieved in 96 % (46/48) of collections.
CONCLUSION: Pre-apheresis total leukocyte count, absolute lymphocyte counts, CD3+ cells, hematocrit, and platelet counts are key factors influencing the successful collection of CD3+ cells during apheresis. Understanding these variables is crucial for optimizing lymphocyte collection for CAR T-cell manufacturing.
METHODS: This exploratory analysis evaluated patients enrolled in the registration phase I/II trials of talicabtagene autoleucel at a tertiary care oncology centre in Western India. Patients were enrolled after obtaining informed consent. The study was approved by the Institutional Ethics Committee and the Central Drugs Standard Control Organisation (CDSCO), and registered with the Clinical Trials Registry of India. A total of 48 autologous lymphocytapheresis procedures were performed on 44 patients with refractory or relapsed lymphoma (predominantly diffuse large B-cell lymphoma) or B-acute lymphoblastic leukemia. Pre-apheresis hematological parameters and flow cytometry were used to estimate absolute lymphocyte counts and peripheral blood CD3+ cell counts. Predictive factors for CD3+ cells in the product were analyzed using the Pearson correlation coefficient and regression models by the Statistical Package for Social Sciences software (Version 25.0, Armonk, NY: IBM Corp.), and p-values <0.05 were considered statistically significant.
RESULTS: Pre-apheresis parameters like total leukocyte count, absolute lymphocyte count, and circulating CD3⁺ cell count were all positively correlated with the absolute CD3+ cell yield in the apheresis product (p < 0.05). Importantly, these associations remained significant in multivariate analysis, highlighting their independent predictive value for the harvested CD3+ count. Additionally, lower pre-apheresis hematocrit and higher platelet levels were independently associated with reduced CD3+ recovery. Notably, the targeted CD3+ cell dose was successfully achieved in 96 % (46/48) of collections.
CONCLUSION: Pre-apheresis total leukocyte count, absolute lymphocyte counts, CD3+ cells, hematocrit, and platelet counts are key factors influencing the successful collection of CD3+ cells during apheresis. Understanding these variables is crucial for optimizing lymphocyte collection for CAR T-cell manufacturing.