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Recruiting Phase 1, Phase 2 NCT05702853

Metabolically Fit CD19 CAR T-cell Therapy With CD34 Selection in Patients With CD19+ Relapsed/Refractory NHL, CLL/SLL

Trial Parameters

Condition B-cell Non Hodgkin Lymphoma
Sponsor Medical University of South Carolina
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 27
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-11-06
Completion 2026-11-06
Interventions
Cyclophosphamide injectionFludarabine InjectionCD19-CD34t metabolically programmed CAR transduced T-cells

Brief Summary

This is a single-center, nonrandomized, open-label dose-escalation study followed by dose-expansion of CD19- CD34t metabolically programmed CAR T-cell therapy in adult patients with relapsed or refractory CD19 B-cell non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

Eligibility Criteria

Inclusion Criteria: Patients eligible for study participation must meet all of the following criteria: 1. Disease Related Criteria Participants must have histologic confirmation of one of the following: 1. CD19+ aggressive non-Hodgkin lymphoma including any of the following subtypes * Diffuse Large B-cell Lymphoma, not otherwise specified * DLBCL, germinal-center B-cell type (GCB) * DLBCL, activated B-cell type (ABC) * T-cell histiocyte-rich B-cell lymphomas (THRBCL) * Primary cutaneous DLBCL, leg type * Intravascular large B cell lymphoma * EBV+ DLBCL, NOS * DLBCL associated with chronic inflammation * HHV8+ DLBCL, NOS * High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangement(double hit lymphoma) * High grade B-cell lymphoma, NOS * Primary mediastinal B-cell lymphoma * B-cell Lymphoma, unclassifiable with features intermediate between DLBCL and Hodgkin lymphoma, as well as with features intermediate between DLBCL and Burkitt lymphoma * Follicular lymphoma grade 3B * Tra

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