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RECRUITING
NCT06752785
PHASE1

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

Sponsor: Guangzhou Women and Children's Medical Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

1 Year - 18 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2024-10-01

Completion Date

2028-06-30

Last Updated

2024-12-31

Healthy Volunteers

No

Interventions

DRUG

CAR-T Therapy

CD19/CD22 CAR-T cell therapy

Locations (1)

Guangzhou Medical University Affiliated Women and Children's Medical Center

Guangzhou, Guangdong, China