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Recruiting EARLY_Phase 1 NCT06446128

A Dose Escalating Study of CD19/CD22/BCMA CAR-T Therapy in Relapsed or Refractory B Cell Non-Hodgkin Lymphoma(NHL)

Trial Parameters

Condition Non-Hodgkin Lymphoma, B-cell
Sponsor Shanghai Cell Therapy Group Co.,Ltd
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 20
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-05-07
Completion 2026-12-31
Interventions
CD19/CD20/BCMA CAR T cells

Brief Summary

This is a single arm, open-label, dose escalation clinical study to evaluate the safety and tolerability of autologous chimeric antigen receptor T (CAR-T) cells targeting CD19/CD22/BCMA in patients with relapsed or refractory B cell non-Hodgkin lymphoma.

Eligibility Criteria

Key Inclusion Criteria: * Patients who are diagnosed with relapsed/refractory B cell non-Hodgkin lymphoma , especially * Diffuse Large B Cell Lymphoma, not other specified (DLBCL,NOS), * Primary Mediastinal Large B Cell Lymphoma (PMBCL) * Transformation Follicular Lymphoma (TFL) * High grade B-cell lymphoma(HGBCL) * High grade B-cell lymphoma (HGBCL) with MYC(myelocytomatosis oncogene) and BCL2(B-cell lymphoma2) /BCL6 (B-cell lymphoma6) rearrangement * Refractory diseases are defined as one of the following * No response to last line of therapy: i. Progressive disease (PD) as best response to most recent therapy regimen; ii. Stable disease (SD) as best response to most recent therapy regimen * Not candidate for autologous stem cell transplant (ASCT) or refractory post-ASCT: i. Disease progression (PD) or relapsed ≤12 months of ASCT (must have biopsy proven recurrence in relapsed individuals) ii. If salvage therapy is given post-ASCT, the individual must have had no response to or relap

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