RecruitingPhase 1Phase 2NCT05702853

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

A Phase 1b Dose Escalation Study of Metabolically Fit CD19 Chimeric Antigen Receptor (CAR) T Cells With CD34 Selection Markers in Adult Patients With Relapsed or Refractory CD19 B-Cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma


Sponsor

Medical University of South Carolina

Enrollment

27 participants

Start Date

Nov 6, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of immune cell therapy (CAR T-cells) for people with certain types of B-cell blood cancers that have come back or stopped responding to treatment. The CAR T-cells are specially engineered to target a protein called CD19, found on the surface of these cancer cells. **You may be eligible if...** - You have a CD19-positive B-cell lymphoma (including DLBCL, follicular lymphoma, mantle cell lymphoma, and others), CLL, or SLL that has relapsed or is not responding to treatment - You have received prior treatment for your cancer - You are in reasonably good health as measured by standard performance scores - Your heart, liver, kidney, and blood counts meet the required levels **You may NOT be eligible if...** - Your cancer does not express the CD19 protein - You have active, uncontrolled infection or autoimmune disease - You have significant heart, lung, liver, or kidney problems - You have had a prior CAR T-cell therapy recently or certain other immune therapies - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCyclophosphamide injection

500 mg/m2 IV over 30-60 minutes +/- 10 minutes before Fludarabine Days -5, -4, - 3

DRUGFludarabine Injection

30 mg/m2 IV over 30-60 minutes +/- 10 minutes after cyclo- phosphamide infusion Days -5, 4, -3

BIOLOGICALCD19-CD34t metabolically programmed CAR transduced T-cells

Cells are to be infused intravenously (IV) over 30 minutes or less via nonfiltered tubing either by gravity or a peristaltic pump, gently agitating the bag during infusion to prevent cell clumping


Locations(1)

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, United States

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NCT05702853


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