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

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.

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Journal
Blood Cancer Journal
Published
2026-07-16
DOI
https://doi.org/10.1038/s41408-026-01569-w
Primary Topic
CAR-T cell therapy research
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article
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article

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

Jayachandran Perumal Kalaiyarasi, Anshul Gupta, Anil Aribandi, N. V. Ramaswamy et al.
Blood Cancer Journal
CAR-T cell therapy research
article

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

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

Abstract

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.

Blood Cancer Journal
Amrita Institute of Medical Sciences and Research Centre (IN), Madras Institute of Orthopaedics and Traumatology (IN), Indraprastha Apollo Hospitals (IN), Malabar Cancer Centre (IN), Apollo Hospitals (IN), The University of Texas MD Anderson Cancer Center (US), Gandhi Medical College & Hospital (IN), Indian Institute of Technology Bombay (IN), Malabar Institute of Medical Sciences (IN), Amala Institute of Medical Sciences (IN), Vardhman Mahavir Medical College & Safdarjung Hospital (IN), Homi Bhabha National Institute (IN), Fortis Healthcare (IN), Tata Memorial Hospital (IN), P. D. Hinduja Hospital and Medical Research Centre (IN), Mahatma Gandhi Memorial Medical College (IN), Cancer Institute (WIA) (IN), Medical Trust Hospital (IN), Max Super Speciality Hospital (IN), CARE Hospitals (IN), Lourdes Hospital (IN), Rajiv Gandhi Cancer Institute and Research Centre (IN), Children's Hospital Colorado (US), Basavatarakam Indo American Cancer Hospital and Research Institute (IN), Mazumdar Shaw Medical Centre (IN), Kovai Medical Center and Hospital (IN), Bhagwan Mahaveer Cancer Hospital and Research Centre (IN), Sir Ganga Ram Hospital (IN), HCG Cancer Hospital (IN), Global Hospitals (IN), Medanta The Medicity (IN), Deenanath Mangeshkar Hospital and Research Center (IN), Apollo Hospitals (IN), Kerala Institute of Medical Sciences (IN), Apollo Hospitals (IN), Kokilaben Dhirubhai Ambani Hospital (IN), Institute of Medical Sciences and Sum Hospital (IN), Kims Bibi Hospital (IN), HCG Cancer Centre (IN), National Cancer Institute (US), Immune Regulation (United Kingdom) (GB), St.John's Medical College Hospital (IN), Center for Cancer Research (US), M S Ramaiah Memorial Hospital (IN), Apollo Proton Cancer Centre (IN), Apollo Hospitals (IN), Sahyadri Hospital (IN), Veeda Clinical Research (India) (IN), Artemis Hospitals (IN), Army Hospital Research and Referral (IN), Institute of Medical Sciences (IN), J.C. Bose University of Science & Technology, YMCA (IN), All India Institute of Medical Sciences (IN), University of Colorado Denver (US)
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