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 - Scorecard - 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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Clinical Scorecard: 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

At a Glance

CategoryDetail
ConditionRelapsed/Refractory B-Acute Lymphoblastic Leukemia (r/r B-ALL) in pediatric, adolescent, and young adult patients
Key MechanismsAdoptive cell immunotherapy using humanized CD19-directed CAR T-cells incorporating a 4–1BB co-stimulatory domain
Target PopulationPediatric and AYA patients aged 3–25 years with r/r B-ALL, ineligible or unable to proceed with allogeneic stem cell transplant, and CD19 expression >99%
Care SettingSpecialized oncology centers with CAR T-cell manufacturing and infusion capabilities (e.g., Tata Memorial Centre and IIT Bombay)

Key Highlights

  • Tali-cel™ (HCAR-19) is an indigenously developed humanized CD19 CAR T-cell product manufactured in India.
  • Phase I/Ib trials tested three dose levels (1 × 10^6, 3–5 × 10^6, and 10–15 × 10^6 CAR T-cells/kg) to determine the optimal phase 2 dose.
  • Trial included patients with r/r B-ALL lacking prior CD19-directed therapy and excluded those with active CNS disease, major comorbidities, or recent allogeneic SCT.

Guideline-Based Recommendations

Diagnosis

  • Confirm r/r B-ALL diagnosis with >99% CD19 expression on blasts and absence of other clones.
  • Exclude patients with isolated extramedullary relapse or active CNS disease.

Management

  • Perform lymphodepletion with fludarabine (30 mg/m2 daily for 3 days) and cyclophosphamide (500 mg/m2 for 2 days) prior to CAR T-cell infusion.
  • Administer Tali-cel™ CAR T-cells at dose levels ranging from 1 × 10^6 to 15 × 10^6 cells/kg based on trial phase and patient tolerance.
  • Use bridging chemotherapy as needed to control disease before CAR T-cell infusion.

Monitoring & Follow-up

  • Monitor for safety and feasibility outcomes as per phase I/Ib trial protocols.
  • Follow patients for at least one year post-infusion to assess long-term efficacy and safety.

Risks

  • Exclude patients with major organ dysfunction, active infections, graft-versus-host disease, pregnancy, or recent investigational therapy use.
  • Monitor for potential adverse events related to CAR T-cell therapy including cytokine release syndrome and neurotoxicity.

Patient & Prescribing Data

Pediatric and AYA patients aged 3–25 years with relapsed/refractory B-ALL, ineligible or unable to proceed with allogeneic SCT, and no prior CD19-directed therapy.

Dose escalation from 1 × 10^6 to 10–15 × 10^6 CAR T-cells/kg was evaluated to determine optimal dosing; bridging chemotherapy and lymphodepletion were integral to treatment protocol.

Clinical Best Practices

  • Ensure multidisciplinary regulatory and ethical approvals prior to trial initiation.
  • Use stringent inclusion/exclusion criteria to select appropriate candidates for CAR T-cell therapy.
  • Coordinate manufacturing and clinical administration closely between specialized centers.
  • Implement bridging chemotherapy to manage disease burden before CAR T-cell infusion.
  • Conduct thorough informed consent processes respecting patient and guardian rights.

References

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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