RecruitingPhase 1NCT06752785

CD19/CD22 CAR-T Cell Therapy in MRD-Positive B-lineage Acute Lymphoblastic Leukemia in Children.

Clinical Study on the Safety and Efficacy of CD19/CD22 CAR-T Cell Therapy in MRD-Positive B-lineage Acute Lymphoblastic Leukemia in Children.

Sponsor

Guangzhou Women and Children's Medical Center

Enrollment

10 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Lymphoblastic Leukemia

Summary

In this study, CD19/CD22 dual-target CAR-T therapy will be carried out among children patients who are still positive after induction remission, and subsequent chemotherapy will continue after CAR-T cells exert their functions. This study intends to use retroviral vector-based tandem CAR-T cells targeting CD19/CD22 to treat MRD-positive ALL. The CAR-T cells were provided by Shenzhen Cell Valley. The results of the research team from Stanford University School of Medicine in the United States have already demonstrated the feasibility and safety of producing bispecific CD19/CD22.BB.z-CAR T cells in a closed system as well as the high clinical activity shown in the treatment of CAR19-resistant B-ALL (B-lineage acute lymphoblastic leukemia) and LBCL (Large B-cell lymphoma). The investigators look forward to expanding the application of CAR-T cells in MRD positive B-ALL through this clinical study on safety and efficacy and greatly improving the prognosis of children patients with this type of B-ALL.

Eligibility

Min Age: 1 YearMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests CAR-T cell therapy — a treatment where a patient's own immune cells are genetically engineered to attack cancer — targeting two proteins on leukemia cells (CD19 and CD22), in children with B-cell acute lymphoblastic leukemia (ALL) that has not fully responded to initial treatment. **You may be eligible if...** - You are a child aged 1–18 years, weighing at least 10 kg - You have B-cell ALL and bone marrow tests still show detectable cancer (MRD-positive) after induction treatment - Your cancer cells express the CD19 and/or CD22 proteins - Your heart, liver, kidney, and lung function are within required ranges - Expected survival of at least 12 weeks **You may NOT be eligible if...** - You have a genetic disease (other than Down syndrome) - You have another active cancer - You have active or chronic hepatitis B or C - You have received a prior stem cell transplant or CAR-T therapy within certain timeframes 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

DRUGCAR-T Therapy

CD19/CD22 CAR-T cell therapy

Locations(1)

Guangzhou Medical University Affiliated Women and Children's Medical Center

Guangzhou, Guangdong, China

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NCT06752785

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