RecruitingPhase 1Phase 2NCT05674175

Co-administration of CART22-65s and huCART19 for B-ALL

Use of Autologous Anti-CD22 CAR T Cells (CART22-65s) Co-administered With Humanized Anti-CD19 CAR T Cells (huCART19) in Children and Young Adults With Relapsed or Refractory B-ALL

Sponsor

Stephan Grupp MD PhD

Enrollment

93 participants

Start Date

Jan 25, 2023

Study Type

INTERVENTIONAL

Conditions

B-cell Acute Lymphoblastic Leukemia B Lineage Lymphoblastic Lymphoma

Summary

This study will evaluate the safety and efficacy of administering two CAR T cell products, huCART19 and CART22-65s, in children with advanced B cell Acute Lymphoblastic Leukemia (B-ALL).

Eligibility

Max Age: 29 Years

Plain Language Summary

Simplified for easier understanding

This study tests giving two CAR-T cell therapies together — CART22-65s (targeting CD22) and huCART19 (targeting CD19) — to patients with B-cell acute lymphoblastic leukemia (B-ALL) that has relapsed or not responded to prior treatment. Using two CAR-T therapies at once may reduce the chance of the cancer escaping by losing one target marker. **You may be eligible if...** - You have confirmed CD19+ and/or CD22+ B-ALL (leukemia cells express at least one of these proteins) - Your leukemia has relapsed, is refractory, or you had a poor response to prior B-cell directed CAR-T therapy - If you have central nervous system (CNS) involvement, it must be responding to treatment - You are in adequate health to receive the therapy **You may NOT be eligible if...** - Your leukemia cells do not express CD19 or CD22 - You have uncontrolled CNS disease - You have severe organ dysfunction or active uncontrolled infections - You do not meet the required blood count thresholds 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 anti-CD22 CAR T cell therapy (CART22-65s)

CART22-65s are autologous T cells that have been engineered to express an extracellular single chain antibody (scFv) with specificity for CD22 linked to an intracellular signaling molecule consisting of a tandem signaling domain comprised of the TCRζ signaling module linked to the 4-1BB costimulatory domain

BIOLOGICALAutologous, humanized anti-CD19 CAR T cell therapy (huCART19)

HuCART19 cells are autologous T cells that have been engineered to express an extracellular single chain antibody (scFv) with specificity for CD19 linked to an intracellular signaling molecule consisting of a tandem signaling domain comprised of the TCRζ signaling module linked to the 4-1BB costimulatory domain