RecruitingPhase 1Phase 2NCT05480449

Autologous HuCART19 T Cells Manufactured Using the CliniMACS Prodigy Platform for Pediatric B-ALL (huCART19 Prodigy)

Phase 1/2b Trial of Autologous Humanized CD19-Directed Chimeric Antigen Receptor T-Cells Manufactured Using the CliniMACS Prodigy Platform for the Treatment of Pediatric B Cell Acute Lymphoblastic Leukemia (B-ALL)


Sponsor

Stephan Grupp MD PhD

Enrollment

115 participants

Start Date

Sep 20, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This study will determine the safety and efficacy of moving to a second-generation manufacturing process using the CliniMACS Prodigy platform to manufacture huCART19 cells for patients with B cell Acute Lymphoblastic Leukemia (B-ALL).


Eligibility

Min Age: 0 YearsMax Age: 29 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a CAR T-cell therapy — a treatment where a patient's own immune cells are re-engineered to attack cancer — for children with B-cell Acute Lymphoblastic Leukemia (B-ALL) or B-cell lymphoma that has come back or has not responded to standard chemotherapy. **You may be eligible if...** - You are a child or young adult with B-cell ALL or B-cell lymphoma confirmed to have the CD19 protein on cancer cells - Your cancer has relapsed (come back) or is refractory (not responding) to at least one or two rounds of prior therapy - You have not previously received CAR T-cell therapy (Cohort A), OR your prior CAR T-cell therapy did not work or your cancer came back (Cohort B) - You are ineligible for or have already had a stem cell transplant **You may NOT be eligible if...** - Your cancer cells do not carry the CD19 protein - You do not meet the specific relapse or treatment failure definitions - You have active, uncontrolled infections or organ failure 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

BIOLOGICALAutologous Humanized CD19-Directed Chimeric Antigen Receptor T-Cells (huCART19)

The investigational agent in this protocol is humanized CART19 cells (huCART19). Autologous T cells will be engineered to express an extracellular single chain antibody (scFv) with specificity for CD19. This will be expected to redirect specificity of the transduced T cells for cells that express CD19, a molecule that is restricted in expression on the surface of the malignant cells and on normal B cells.


Locations(1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

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NCT05480449


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