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<p>Talicabtagene autoleucel (tali-cel) is the first humanized CD19-directed CAR-T cell therapy approved in India for relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL) and B-cell non-Hodgkin lymphoma (B-NHL). Here, we integrated clinical and manufacturing operations through a centralized coordination unit (CCU) and evaluated tali-cel implementation. Patients with r/r B-ALL (<i>n</i> = 105) and r/r B-NHL (<i>n</i> = 145) who underwent leukapheresis between 15 November 2023 and 31 January 2025 across 56 treatment centers were included. The CCU enabled timely delivery, with manufacturing slot allocation within one week of slot request and a median vein-to-vein time of 29 days (range, 16–102), independent of geographic location. In r/r B-ALL patients, the median follow-up was 14 months, and the median overall survival (OS) not reached, and progression-free survival (PFS) was 18 months (range: 9-NR). The 12-month OS and PFS were 64% (95% CI: 53–72) and 55% (95% CI: 45–65). In r/r B-NHL, the median follow-up was 13 months and the median PFS was 11 months (range:7–16) and OS was not reached. The 12-month OS and PFS were 63% (95% CI: 54–71) and 47% (95% CI: 38-56). No patients underwent consolidative stem cell transplantation. Grade 3/4 cytokine release syndrome (CRS), immune effector cell–associated neurotoxicity syndrome (ICANS), and Immune Effector Cell-associated Hemophagocytic Lymphohistiocytosis-like Syndrome (IEC-HS) occurred in 6%, 4%, and 23% of r/r B-ALL and 6%, 3%, and 18% of r/r B-NHL patients, respectively. These findings demonstrate the successful implementation of tali-cel across multiple centers in a large cohort, which might contribute towards improving CAR-T access globally.</p>

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Enabling access to talicabtagene autoleucel in relapsed/refractory B-cell malignancies; multicenter real-world evidence on delivery, efficacy and safety

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月16日

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  • Atharva Karulkar,
  • Hasmukh Jain,
  • Neeraj Sidharthan,
  • Dinesh Bhurani,
  • Sameer Melinkeri,
  • Pavan Kumar Boyella,
  • Prashant Mehta,
  • Esha Kaul,
  • Sanket Shah,
  • Jayachandran P. K.,
  • Chandran Nair,
  • Rahul Bhargava,
  • Bhausaheb Bagal,
  • Lingaraj Nayak,
  • Alok Shetty,
  • Hari Menon,
  • Rakesh Reddy Boya,
  • Ram Abhinav,
  • Devanshi Kalra,
  • Smrithi Ravikumar,
  • Jayashree Thorat,
  • Abhijit Baheti,
  • Abhishek Charan,
  • Ajay Gupta,
  • Akshay Lahoti,
  • Amul Kapoor,
  • Anil Aribandi,
  • Anshul Gupta,
  • Anupam Chakrapani,
  • Bijay P. Nair,
  • Bilal Kazi,
  • Gaurav Dixit,
  • Girish Badarkhe,
  • Hemant Malhotra,
  • Kannan Subramanian,
  • Kaushal Kalra,
  • Kishore Kumar,
  • Kripa Bajaj,
  • Kunal Goyal,
  • Narendra Anukonda,
  • Padmaja Lokireddy,
  • Parathan Karunakaran,
  • Prakash Singh Shekhawat,
  • Prasad Narayanan,
  • Priyanka Samal,
  • Punit Jain,
  • Rajan Kapoor,
  • Rajat Bhattacharya,
  • N. V. Ramaswamy,
  • Ranjit Sahoo,
  • Rayaz Ahmed,
  • Rumesh Chandar,
  • S. K. Gupta,
  • Sainath Bhethanabhotla,
  • Sameer Tulpule,
  • Santhosh Kumar,
  • Sharat Damodar,
  • Shyam Aggarwal,
  • Sudeep Vaniyath,
  • Sumita Chaudhary,
  • Sunu Cyriac,
  • Suraj Chiraniya,
  • T. Raja,
  • T. Rajshekhar,
  • Varun Rajan,
  • Vasu Babu Goli,
  • Velu Nair,
  • Vijay Patil,
  • Vishwanath Sathyanarayanan,
  • Mohammed Sadique Ansari,
  • Anjali Jaiswal,
  • Yuktam Yadav,
  • Sakshi Soni,
  • Karan Gera,
  • Manivasagam Sundharam,
  • Shreshtha Shah,
  • Afrin Firfiray,
  • Pranali Patil,
  • Juber Pendhari,
  • Rohit Beher,
  • Hema Hotchandani,
  • Anupa John,
  • Shalini Purwar,
  • Nirali N. Shah,
  • Terry Fry,
  • Nitin Jain,
  • Sattva Neelapu,
  • Manju Sengar,
  • Rahul Purwar

摘要

Talicabtagene autoleucel (tali-cel) is the first humanized CD19-directed CAR-T cell therapy approved in India for relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL) and B-cell non-Hodgkin lymphoma (B-NHL). Here, we integrated clinical and manufacturing operations through a centralized coordination unit (CCU) and evaluated tali-cel implementation. Patients with r/r B-ALL (n = 105) and r/r B-NHL (n = 145) who underwent leukapheresis between 15 November 2023 and 31 January 2025 across 56 treatment centers were included. The CCU enabled timely delivery, with manufacturing slot allocation within one week of slot request and a median vein-to-vein time of 29 days (range, 16–102), independent of geographic location. In r/r B-ALL patients, the median follow-up was 14 months, and the median overall survival (OS) not reached, and progression-free survival (PFS) was 18 months (range: 9-NR). The 12-month OS and PFS were 64% (95% CI: 53–72) and 55% (95% CI: 45–65). In r/r B-NHL, the median follow-up was 13 months and the median PFS was 11 months (range:7–16) and OS was not reached. The 12-month OS and PFS were 63% (95% CI: 54–71) and 47% (95% CI: 38-56). No patients underwent consolidative stem cell transplantation. Grade 3/4 cytokine release syndrome (CRS), immune effector cell–associated neurotoxicity syndrome (ICANS), and Immune Effector Cell-associated Hemophagocytic Lymphohistiocytosis-like Syndrome (IEC-HS) occurred in 6%, 4%, and 23% of r/r B-ALL and 6%, 3%, and 18% of r/r B-NHL patients, respectively. These findings demonstrate the successful implementation of tali-cel across multiple centers in a large cohort, which might contribute towards improving CAR-T access globally.