RecruitingEarly Phase 1NCT06696833

Allogeneic CD19-targeted CAR-γδT Cell Infusion Therapy in Relapsed/Refractory B Cell Acute Lymphoblastic Leukemia

Assessment of the Safety and Efficacy of Allogeneic CD19-targeted CAR-γδT Cell Infusion Therapy in Relapsed/Refractory B Cell Acute Lymphoblastic Leukemia: A Single-Arm, Open-Label, Prospective Study


Sponsor

The First Affiliated Hospital of Soochow University

Enrollment

18 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This clinical trial aims to investigate the safety, optimal dosage, and effectiveness of allogeneic CD19-targeted CAR-γδT Cell in treating CD19-positive relapsed/refractory B-ALL


Eligibility

Min Age: 14 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an advanced cell therapy called CAR-T cell therapy using donor cells to treat B-cell acute lymphoblastic leukemia (B-ALL, a type of blood cancer) that has come back or stopped responding to standard treatments. **You may be eligible if...** - You are 14 years old or older - You have been diagnosed with B-cell ALL - Your leukemia has relapsed (come back) or has not responded to prior treatment - You have bone marrow or blood involvement from the cancer **You may NOT be eligible if...** - Your relapse is entirely outside the bone marrow (isolated extramedullary relapse only) - You have severe organ dysfunction - You have active uncontrolled infections - You do not meet organ function requirements for this therapy 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

BIOLOGICALQH10304-BAL-01

dose escalation (3+3) : dose 1 (3 × 10\^8cells/kg) ,dose 2 (1 × 10\^9 cells/kg) ,dose 3 (3 × 10\^9cells/kg)

DRUGFludarabine

Intravenous fludarabine 30mg/m2 on days-6 to -3,the infusion dose is adjusted according to the subject's condition

DRUGCyclophosphamide

Intravenous cyclophosphamide 1000mg/m2 on days -5 to -3, the infusion dose is adjusted according to the subject's condition


Locations(1)

The First Affiliated Hospital of Soochow University

Suzhou, China, Jiangsu, China

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NCT06696833