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An observational study to find out the safety and effectiveness of NexCAR19 cell therapy in treating relapsed or treatment-resistant B-cell cancers in adolescent and adult participants to see how long the disease can be kept under control

An observational study evaluating the safety and efficacy of NexCAR19 (2nd generation Anti-CD19-4-1BB-CD3-zeta chimeric antigen receptor T-cell therapy) in adolescent and adult patients with relapsed/refractory B-cell malignancies - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/08/093795
Enrollment
10000
Registered
2025-08-27
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C833- Diffuse large B-cell lymphoma Health Condition 2: C820- Follicular lymphoma grade I Health Condition 3: C821- Follicular lymphoma grade II Health Condition 4: C823- Follicular lymphoma grade IIIa Health Condition 5: C824- Follicular lymphoma grade IIIb Health Condition 6: C831- Mantle cell lymphoma Health Condition 7: C859- Non-Hodgkin lymphoma, unspecified Health Condition 8: C91Z- Other lymphoid leukemia Health Condition 9: C851- Unspecified B-cell lymphoma

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: NIL: NIL Intervention4: Nil: Nil Intervention5: Nil: Nil Control Intervention1: NIL: NIL

Sponsors

Immunoadoptive Cell Therapy Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with age more than or equal to 15 years diagnosed with: Relapsed/ Refractory B Cell Lymphomas. Relapsed/ Refractory B- Acute Lymphoblastic Leukaemia. 2. Patients who are planned to receive NexCAR19. 3. Willing to give consent (for Prospective Part of the study).

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

MeasureTime frame
To evaluate the Progression free survivalTimepoint: Day 28, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 36, Month 48 & Month 60—

Secondary

MeasureTime frame
1.To assess the overall Survival 2.To assess the event free survival 3.To assess the Overall Response Rate, Duration of Response 4.Incidence of serious unexpected adverse drug reactions & adverse events of special interest. 5.To evaluate the safety by recording the adverse events including grade III/IV adverse events 6.To study the factors Disease/Patient/Product that influence the efficacy & safety outcomes. This includes but not limited to blast %, refractory/relapsed to the prior lines of therapy, age, bridging therapy, prior lines of therapy, patterns of infection, factors contributing to complications or adverse events, apheresis product & final product characteristics. 7.To develop a supervised binary classification model to predict adverse reactions in patients undergoing CAR-T cell therapy. 8.To look for late complications such as secondary malignancies 9.Healthcare Resource Utilisation Timepoint: Day 28, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 36, Month 48 & Month 60—

Countries

India

Contacts

Public ContactDr Hasmukh Jain

Tata Memorial Hospital

dr.hkjain@gmail.com02224177018

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026