RAD3CAR is a phase I study designed to evaluatethe safety of B7-H3-CAR T cells and lymphodepletion in combination with hypofractionated radiation therapy. Primary objective: \- To evaluate the safety of B7-H3-CAR T cell therapy after priming with hypofractionated radiation therapy (HFRT) and lymphodepleting chemotherapy in patients ≤ 21 years of age with relapsed/refractory B7-H3+ sarcomas. Secondary objectives: * To describe the antitumor activity of B7-H3-CAR T cells in combination with HFRT * To determine if B7-H3-CAR T cells traffic to tumor sites after combination treatment with HFRT
This study is a phase I study designed to describe the safety of B7-H3-CAR T cells and lymphodepletion in combination with hypofractionated radiation therapy for the treatment of pediatric patients with B7-H3+ sarcoma. The study will contain two-part eligibility criterion: one to proceed with autologous apheresis and manufacturing of CAR T cells, and a second to proceed with CAR T cell treatment. The primary intervention is the administration of autologous B7-H3-CAR T cells, after priming with HFRT and administration of lymphodepleting chemotherapy. Peripheral blood mononuclear cells (PBMC) will be collected by autologous apheresis. Treatment will include HFRT to at least one site of disease, administered in parallel with a single course of lymphodepleting chemotherapy (fludarabine/cyclophosphamide) and followed by CAR T cell infusion. Participants are evaluated for a post-treatment tumor biopsy and may choose to be evaluated for a pre-treatment tumor biopsy. Participants who meet specified criteria will be eligible for optional additional treatment courses.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Intravenously on day -5, -4, -3 and -2
Intravenously on day -3, -2
Intravenously on day 0
5 or 8 treatment sessions (fractions), scheduled to complete on Day -2
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
RECRUITINGDose limiting toxicity (DLT) rate
Proportion of evaluable participants experiencing DLTs
Time frame: up to 4 weeks after CAR T cell infusion
Incidence of adverse events (AEs)
AEs will be assessed and graded using CTCAE v5.0, except for cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS), which will be graded according to ASTCT consensus guidelines. AEs will be summarized and reported descriptively
Time frame: up to 4 weeks after CAR T cell infusion
Clinical antitumor activity
Best overall response after treatment as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and if applicable bone marrow evaluation
Time frame: 4-12 weeks after CAR T cell infusion
B7-H3-CAR T cell trafficking to tumor sites
Evaluate for the presence of B7-H3-CAR T cells in post-treatment tumor biopsies
Time frame: 2 weeks after CAR T cell infusion
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