Safety, efficacy and total cost of point-of-care manufactured anti-CD19 CAR-T cell therapy in India: VELCART trial

Safety, efficacy and total cost of point-of-care manufactured anti-CD19 CAR-T cell therapy in India: VELCART trial

Decentralized or point-of-care (POC) manufacture of CAR-T cells is a potential strategy to improve accessibility and reduce cost and logistic challenges. A total of 10 relapsed/refractory patients (B cell acute lymphoblastic leukemia [B-ALL] N = 6, diffuse large B cell lymphoma [DLBCL] N = 4) were e...

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Main Authors: Hamenth Kumar Palani, Arun Kumar Arunachalam, Uday Kulkarni, Mohammed Yasar, Arvind Venkatraman, Swathy Palanikumar, Reeshma Nair Radhakrishnan, Majeela Solomon, Abirami Rajasekaran, Aniket Bankar, Phaneendra Venkateswara Rao Datari, Sushil Selvarajan, Anu Korula, Pradyot Dash, Dina Schneider, Louisa Wirthlin, Aby Abraham, Biju George, Vikram Mathews
Format: Article
Language:English
Published: Elsevier 2025-06-01
Series:Molecular Therapy: Oncology
Subjects:
MT: Regular Issue
CART-cell therapy
point-of-care manufacturing
CliniMACS Prodigy
cost analysis
decentralized manufacturing
Online Access:http://www.sciencedirect.com/science/article/pii/S2950329925000463
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Summary:Decentralized or point-of-care (POC) manufacture of CAR-T cells is a potential strategy to improve accessibility and reduce cost and logistic challenges. A total of 10 relapsed/refractory patients (B cell acute lymphoblastic leukemia [B-ALL] N = 6, diffuse large B cell lymphoma [DLBCL] N = 4) were enrolled in this POC phase 1 study. Chimeric antigen receptor (CAR)-T cells were manufactured using the fully automated CliniMACS Prodigy system. The CAR-T cell products had a median 15-fold expansion with a median transduction rate of 38%. The immunophenotypic characterization indicates a significant increase in central memory and effector T cells. All the patients were infused with fresh CAR-T cells. Complete remission rates were 100% for B-ALL and 50% for DLBCL. At a median follow-up of 15 months, 8 of 10 patients remain without disease progression. Adverse events reported were cytokine release syndrome grade 2 or higher in 2 of 10 patients. None of the patients developed immune effector cell-associated neurotoxicity syndrome. Late hematological toxicity of grade 2 or higher was noted only in one patient. Evaluation of health care resource utilization demonstrates that the median cost was US$12,724, while the manufacturing cost was US$35,107. Our data highlight the safety, efficacy, low cost, and potential to enhance the accessibility of CAR-T cell therapy in low- and middle-income countries through a fully automated and closed manufacturing platform.
ISSN:2950-3299

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