A Phase 1 clinical trial to evaluate the safety and early efficacy of CAR T-cells with IL-7Ra signal targeting B7H3 in children with solid tumors patients after complete standard treatments.
Currently, treatment options for pediatric solid tumors that have recurred or are unresponsive to standard treatments are limited. These cancers often do not respond to other chemotherapy drugs or targeted therapies available today. As a result, there is currently no effective treatment for pediatric solid tumors that have recurred or are unresponsive to standard treatments. At present, immunotherapy for cancer treatment is being developed. This involves genetically modifying the patient\'s immune cells to target specific cancer cells, known as CAR T cells. This approach is used to treat recurrent or unresponsive solid tumors and brain cancers that do not respond to standard treatments. The research aims to study the efficacy and safety of treating pediatric patients with recurrent or unresponsive solid tumors using a type of immunotherapy called CAR T cells. These cells are engineered to express a chimeric antigen receptor that includes an interleukin-7 receptor alpha signaling domain and targets the B7-H3 antigen on tumor surfaces. This research is the first of its kind conducted on Thai patients. The research team expects this treatment to be highly safe and effective in controlling cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Autologous T cells lentiviral transduced to express a B7H3-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
RECRUITINGSafety and tolerability of B7H3-IL7Ra CAR T cells infusion in solid tumors 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 B7H3-IL7Ra CAR-T cell infusion
The overall response rate of solid tumors
The overall response rate will be assessed using radiologic response criteria that use the standard sum of the two longest 2D perpendicular diameters to distinguish stable disease, progressive disease (\>25% increase), partial response (\>50% decrease), and complete response (no evaluable or measurable disease).
Time frame: 1, 3, 6, and 12 months after B7H3-IL7Ra CAR-T cell infusion
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