RecruitingPhase 2NCT05470777

CD22/CD19 CAR-T and Auto-HSCT Sandwich Strategy as Consolidation Therapy for B-ALL

Safety and Efficacy of CD22/CD19 CAR T-cells and Autologous HSCT Sandwich Strategy as Consolidation Therapy for B-cell Acute Lymphoblastic Leukemia

Sponsor

The First Affiliated Hospital of Soochow University

Enrollment

37 participants

Start Date

Jan 19, 2020

Study Type

INTERVENTIONAL

Conditions

B-cell Acute Lymphoblastic Leukemia

Summary

Chimeric antigen receptor T-cell (CAR-T) therapy has achieved remarkable efficacy in B-cell acute lymphoblastic leukemia (B-ALL). However, relapse after CAR-T has been a major issue. Multi-antigen CAR T and combination with other regimens may reduce the relapse rate. The investigators first conducted CD22/CD19 CAR T-cells and auto-HSCT "sandwich " strategy as consolidation therapy in patients with B-ALL. The main Purpose of this study was to observe the safety and efficacy of this new strategy.

Eligibility

Min Age: 15 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a CAR-T cell therapy that targets two proteins (CD19 and CD22) on cancer cells, combined with a stem cell transplant using the patient's own cells, as a consolidation treatment for B-cell acute lymphoblastic leukemia (B-ALL) — a type of blood cancer. **You may be eligible if...** - You have been diagnosed with B-ALL (a type of blood cancer affecting white blood cells) - You either don't have a suitable donor for a standard stem cell transplant, or you have declined a donor transplant - Your cancer cells test positive for both CD19 and CD22 proteins - You are between 15 and 65 years old **You may NOT be eligible if...** - Your cancer has only spread outside the bone marrow (isolated extramedullary disease) without bone marrow involvement - You have had previous treatment with anti-CD19 or anti-CD22 therapies - You have HIV, active hepatitis B or C, or uncontrolled infections - You have significant heart, liver, kidney, or lung problems 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

COMBINATION_PRODUCTCD22/CD19 CAR T and auto-HSCT "sandwich" strategy

The patients received sequential infusion of CD22 and CD19 CAR-T cells (co-stimulatory molecule was 4-1BB and infusion dose was 5\*10\^6/kg respectively) after standard induction and consolidation chemotherapy. Autologous stem cells mobilization and collection were performed 6-8 weeks after CAR-T infusion. Modified BuCy as conditioning regimen for Auto-HSCT was used 4 weeks after successful stem cell collection. CD22 and CD19 CAR-T cells were re-infused 2 days after Auto-HSCT. Patients were followed up and minimal residual diseases (MRD) was monitored by flow cytometry and second-generation gene sequencing of IgH rearrangement.