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 - Takeaways - MDSpire

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

  • By

  • Gaurav Narula

  • Swaminathan Keerthivasagam

  • Hasmukh Jain

  • Sachin Punatar

  • Akanksha Chichra

  • Chetan Dhamne

  • Prashant Tembhare

  • Papagudi Ganesan Subramanian

  • Nikhil Patkar

  • Minal Poojary

  • Anant Gokarn

  • Sumeet Mirgh

  • Nishant Jindal

  • Albeena Nisar

  • Deepali Pandit

  • Khushali Pandit

  • Alka Dwivedi

  • Atharva Karulkar

  • Ankesh Kumar Jaiswal

  • Aalia Khan

  • Shreshtha Shah

  • Afrin Rafiq

  • Moumita Basu

  • Juber Pendhari

  • Sweety Asija

  • Ambalika Chowdury

  • Ankit Banik

  • Nirmalya Roy Moulik

  • Shyam Srinivasan

  • Shilpushp Bhosle

  • Sumathi Hiregoudar

  • Shashank Ojha

  • Lingaraj Nayak

  • Jayshree Thorat

  • Bhausaheb Bagal

  • Manju Sengar

  • Navin Khattry

  • Shripad Banavali

  • Steven Highfill

  • Nirali N. Shah

  • Rahul Purwar

  • April 24, 2025

  • 0 min

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  • 1

    The study focuses on a novel humanized CD19-CAR-T therapy, talicabtagene autoleucel, for pediatric patients with relapsed/refractory B-ALL.

  • 2

    Survival rates for pediatric B-ALL exceed 90% in developed countries, but outcomes for relapsed/refractory cases remain poor.

  • 3

    The pilot Phase 1 trial tested the safety and feasibility of HCAR-19 in patients aged 3-25 years, with a focus on dose optimization.

  • 4

    Regulatory approval for the trial involved multiple oversight bodies, highlighting the complexities of conducting gene therapy studies.

  • 5

    The study aims to improve access to CAR T-cell therapies in India, addressing the prohibitive costs that limit availability in low-income regions.

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