A Phase 1 clinical trial to evaluate the safety and early efficacy of CAR T-cells with IL-7Rα signaling targeting CD19 in children with relapsed and refractory B-cell acute lymphoblastic leukemia after complete standard treatments.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
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
King Chulalongkorn Memorial Hospital
Bangkok, Pathumwan, Thailand
Safety and tolerability of CD19-IL7Ra CAR T-cells infusion in B-cell acute lymphoblastic leukemia patients.
The incidence of adverse events assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0
Time frame: 7 days, 14 days, 21 days, 30 days, 60 days, 90 days, 6 months and 12 months after CD19-IL7Ra CAR-T cell infusion
The overall response rate of B-cell acute lymphoblastic leukemia
The overall response rate will be assessed using standard response criteria for acute lymphoblastic leukemia patients through a combination of clinical, hematologic, and molecular assessments. The response categories are Minimal Residual Disease (MRD), Complete Response (CR), Complete Response with Incomplete Count Recovery (CRi), Stable Disease (SD), and Progressive Disease (PD).
Time frame: 30 days, 60 days, 90 days, 6 months and 12 months after CD19-IL7Ra CAR-T cell infusion
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