NCT06752785

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.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Guangzhou Women and Children's Medical Center · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This clinical trial is a single-center, open-label, single-arm clinical trial to evaluate the safety and efficacy of CAR-T cell treatment for MRD-positive B-ALL. The specific trial process is divided as follows: 1. Screen the enrolled population to determine the indications and exclusion criteria for cell treatment. In brief, intermediate-risk patients with positive MRD on day 46 of induction through flow cytometry according to CCCG-ALL regimen. 2. Sign the informed consent form. 3. CAR-T cell preparation: collect autologous lymphocytes and produce CAR-T cells targeting the CD19/CD22 target. 4. Lymphocyte depletion pretreatment: according to the patient's condition, select the FC regimen (fludarabine 30 mg/m²/day for 4 days; cyclophosphamide 500 mg/m²/day for 2 days) before autologous transplantation. 5. Cell intravenous infusion: dose: 3 × 10⁶/kg (allowable fluctuation range: 2 × 10⁶/kg - 4 × 10⁶/kg). Obeserve adverse reactions including CRS and ICANS. 6. Evaluate the efficacy after the first cell infusion by MRD test . 7. Continue chemotherapy after one month of CART according CCCG-ALL regimen from the second high-dose MTX of consolidation stage. 8. Follow-up after the completion of the clinical study: within the first month after cell infusion, the subject needs to complete the relevant examinations required for follow-up on the 7th, 14th, 21st, and 30th days. Depending on the patient's condition, the number of detections may also be increased; from the 2nd to 6th months after infusion, follow-up once a month; from 6 months to 2 years after infusion, follow-up once every 3 months. From 2 to 5 years after infusion, follow-up once a year. After that, enter long-term follow-up.

Conditions

• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	CAR-T Therapy	CD19/CD22 CAR-T cell therapy

Timeline

• Start date: 2024-10-01
• Primary completion: 2027-12-31
• Completion: 2028-06-30
• First posted: 2024-12-31
• Last updated: 2024-12-31

Locations

1 site across 1 country: China