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 - Summary - MDSpire
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Humanized CD19-CAR-T Cells (Talicabtagene Autoleucel, Tali-cel™) in Pediatric Patients with Relapsed/Refractory B-Acute Lymphoblastic Leukemia: Results from an Open-Label Phase I/Ib Trial

  • 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

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Objective:

To evaluate the safety and feasibility of HCAR-19, a novel humanized CD19-directed CAR T-cell therapy, in pediatric patients with relapsed/refractory B-acute lymphoblastic leukemia (B-ALL), focusing on primary endpoints of safety and feasibility.

Key Findings:
  • The study demonstrated the feasibility and safety of HCAR-19 in the targeted patient population.
  • Initial dosing adjustments were made based on early patient responses.
  • The trial provided valuable data for determining the optimal Phase 2 dose.
Interpretation:

The results indicate that HCAR-19 may be a promising treatment option for pediatric patients with r/r B-ALL, addressing a significant unmet need in this population.

Limitations:
  • The study was limited by its small sample size and single-arm design.
  • Results may not be generalizable to all populations due to specific inclusion criteria.
Conclusion:

HCAR-19 shows potential as a safe and effective therapy for pediatric patients with relapsed/refractory B-ALL, warranting further investigation in larger trials.

Original Source(s)

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

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