Novel humanized CD19-CAR-T (Now talicabtagene autoleucel, Tali-cel™) cells in relapsed/ refractory pediatric B-acute lymphoblastic leukemia- an open-label single-arm phase-I/Ib study.

• Tác giả: Sweety Asija, Bhausaheb Bagal, Shripad Banavali, Ankit Banik, Moumita Basu, Shilpushp Bhosle, Akanksha Chichra, Ambalika Chowdury, Chetan Dhamne, Alka Dwivedi, Anant Gokarn, Steven Highfill, Sumathi Hiregoudar, Hasmukh Jain, Ankesh Kumar Jaiswal, Nishant Jindal, Atharva Karulkar, Swaminathan Keerthivasagam, Aalia Khan, Navin Khattry, Sumeet Mirgh, Nirmalya Roy Moulik, Gaurav Narula, Lingaraj Nayak, Albeena Nisar, Shashank Ojha, Deepali Pandit, Khushali Pandit, Nikhil Patkar, Juber Pendhari, Minal Poojary, Sachin Punatar, Rahul Purwar, Afrin Rafiq, Manju Sengar, Nirali N Shah, Shreshtha Shah, Shyam Srinivasan, Papagudi Ganesan Subramanian, Prashant Tembhare, Jayshree Thorat
• Ngôn ngữ: eng
• Ký hiệu phân loại: 784.190288 General principles, musical forms, instruments
• Thông tin xuất bản: United States : Blood cancer journal , 2025
• Bộ sưu tập: NCBI
• ID: 743812

Tóm tắt

Chimeric Antigen Receptor-T (CAR-T) cell therapy is effective for relapsed/refractory B-acute lymphoblastic leukemia (r/r B-ALL) but is not universally available. We developed a novel humanized CD19-directed CAR-T (HCAR19) approved for Phase 1/1b/2 trials. Patients aged 3-25 years were enrolled with r/r B-ALL and ineligible for allogeneic stem cell transplant. Lymphodepletion utilized standard-dose fludarabine and cyclophosphamide. A 3 + 3 design testing 3 dose-ranges was used to determine Phase-2 Dose (P2D): Dose-A, 1 × 10