RecruitingNot ApplicableNCT06343090

Clinical Trial of CD19 and CD22 CAR Sequential Therapy Versus Single CD19 CAR Bridging to HSCT for r/r B-ALL Patients

Pragmatic Clinical Trial of CD19 and CD22 CAR T-cell Sequential Therapy Versus Single CD19 CAR T-cell Bridging to Transplantation for Patients With Refractory or Relapsed B-cell Acute Lymphoblastic Leukemia

Sponsor

Beijing GoBroad Hospital

Enrollment

353 participants

Start Date

Apr 12, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Lymphoblastic Leukemia, in Relapse B-cell Acute Lymphoblastic Leukemia Refractory Acute Lymphoid Leukemia

Summary

This is a multi-center, open-label, non-randomized, two-arm, non-inferior trial. Patients with r/r B-ALL would be assigned to the CD19 CAR and CD22 CAR T-cell sequential infusion group (Sequential CAR, Arm-1) and the CD19 CAR T-cell infusion bridging to hematopoietic stem cell transplantation group (CAR+HSCT, Arm-2), according their own discretion. Patients would be also allowed to assigned to the CD19 CAR T-cell infusion without consolidation therapies group (Single CAR, additional placebo arm) according their own discretion. The primary objective is to prospectively evaluate and compare the efficacy of CD19 CAR and CD22 CAR T cell sequential infusions and CD19 CAR T-cell infusion bridging to HSCT in the treatment of r/r B-ALL. The primary endpoint is event-free survival of children and adolescent and young adult (AYA) with r/r B-ALL a treated with CD19 CAR and CD22 CAR T-cell sequential infusions and CD19 CAR T-cell infusion bridging to HSCT. A total number of 353 subjects will be enrolled.

Eligibility

Min Age: 1 YearMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study compares two CAR-T cell therapy approaches for patients with relapsed or refractory B-cell acute lymphoblastic leukemia (a type of blood cancer) — using CAR-T cells that target two different proteins on cancer cells (CD19 and CD22) in sequence, versus using only a single CD19 CAR-T therapy as a bridge to a stem cell transplant. **You may be eligible if...** - You have been diagnosed with relapsed or refractory B-cell acute lymphoblastic leukemia that has come back or not responded to prior treatment - Your cancer meets specific diagnostic criteria including having at least 20% leukemia cells in the bone marrow - You have had adequate prior treatment as per study guidelines - Your organ function is sufficient for CAR-T cell therapy **You may NOT be eligible if...** - Your cancer has spread to the brain and spinal cord in an uncontrolled way - Your organ function is too impaired - You have active serious infections - 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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