{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Palani HK"],"funding":["Indian Council of Medical Research"],"pagination":["200977"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC12005290"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["33(2)"],"pubmed_abstract":["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] <i>N</i> = 6, diffuse large B cell lymphoma [DLBCL] <i>N</i> = 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."],"journal":["Molecular therapy. Oncology"],"pubmed_title":["Safety, efficacy and total cost of point-of-care manufactured anti-CD19 CAR-T cell therapy in India: VELCART trial."],"pmcid":["PMC12005290"],"funding_grant_id":["91/06/2020-TFGTR/ BMS"],"pubmed_authors":["Abraham A","Arunachalam AK","Palanikumar S","Rajasekaran A","George B","Korula A","Solomon M","Selvarajan S","Kulkarni U","Venkatraman A","Wirthlin L","Dash P","Schneider D","Mathews V","Palani HK","Radhakrishnan RN","Datari PVR","Yasar M","Bankar A"],"additional_accession":[]},"is_claimable":false,"name":"Safety, efficacy and total cost of point-of-care manufactured anti-CD19 CAR-T cell therapy in India: VELCART trial.","description":"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] <i>N</i> = 6, diffuse large B cell lymphoma [DLBCL] <i>N</i> = 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.","dates":{"release":"2025-01-01T00:00:00Z","publication":"2025 Jun","modification":"2025-07-12T03:04:18.464Z","creation":"2025-07-12T03:04:18.464Z"},"accession":"S-EPMC12005290","cross_references":{"pubmed":["40248244"],"doi":["10.1016/j.omton.2025.200977"]}}