NCT07078929

Clinical Trial of CMD63 Chimeric Antigen Receptor T-cell (CAR T-cell) in Children With Acute Lymphoblastic Leukemia (ALL)

Safety and Preliminary Efficacy of CD19 With IL-7 Receptor Alpha Signaling Chimeric Antigen Receptor T Cell (CMD63) in Relapse and Refractory Pediatric B-cell Acute Lymphoblastic Leukemia

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Chulalongkorn University · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase 1 clinical trial to evaluate the safety and early efficacy of Chimeric Antigen Receptor T-cell (CAR T-cell) with IL-7Rα signaling targeting CD19 in children with relapsed and refractory B-cell Acute Lymphoblastic Leukemia (ALL) after complete standard treatments.

Detailed description

Hematological cancers are a significant public health problem in Thailand. Currently, treatment outcomes for patients with B-cell leukemia using standard chemotherapy regimens show satisfactory disease control and survival rates. However, patients with relapsed or refractory disease have very limited treatment options, as the chance of achieving remission through chemotherapy or targeted therapies before bone marrow transplantation is less than 20%. Once patients experience relapse or become refractory to treatment, their chance of surviving more than one year is extremely low. Therefore, developing new treatments for relapsed or refractory B-cell leukemia is urgently needed to provide additional treatment options, increase response rates, and improve survival outcomes in these patients. Phase 1 to Phase 3 clinical research studies worldwide have demonstrated that treating patients with relapsed or refractory B-cell leukemia using the patients' own genetically modified T cells that specifically target B-cell leukemia and lymphoma cells can control the disease in 70-90% of B-cell leukemia patients. Approximately 50-60% of patients survive without disease recurrence for more than one year after treatment, with manageable side effects. For these reasons, this research project aims to study the safety of treating Thai pediatric patients with relapsed or refractory B-cell leukemia using the patients' own T cells that have been genetically modified to become chimeric antigen receptor T cells specifically targeting proteins on the surface of leukemia cells. This research is being conducted for the first time in Thai pediatric patients. The research team expects this treatment to be highly safe and effective in controlling B-cell leukemia.

Conditions

• Relapse B Acute Lymphoblastic Leukemia
• Refactory Childhood Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	CD19-IL7Ra CAR-T cells	Autologous T cells lentiviral transduced to express a CD19-specific chimeric antigen receptor (CAR) with the addition of an IL-7 receptor alpha signaling domain, administered via central venous access catheter after lymphodepletion

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-09-01
• Completion: 2028-09-01
• First posted: 2025-07-22
• Last updated: 2026-03-02

Locations

3 sites across 1 country: Thailand