Actively Recruiting
Hypofractionated Radiation in Combination With B7-H3-CAR T Cells for Pediatric Patients With Relapsed/Refractory Sarcomas
Led by St. Jude Children's Research Hospital · Updated on 2026-02-09
42
Participants Needed
1
Research Sites
302 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Hypofractionated Radiation in Combination With B7-H3-CAR T Cells for Pediatric Patients With Relapsed/Refractory Sarcomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21 years or younger
- Diagnosed with B7-H3 positive sarcoma confirmed by immunohistochemistry with H score ≥ 100
- Sarcoma types include osteosarcoma, Ewing sarcoma, rhabdomyosarcoma, or non-rhabdomyosarcoma soft tissue sarcomas
- Evidence of relapsed or refractory disease after standard first-line therapy
- At least one lesion suitable for hypofractionated radiation therapy
- For dose expansion: additional evaluable disease beyond planned radiation field
- Estimated life expectancy greater than 12 weeks (for collection/manufacturing) and greater than 8 weeks (for treatment)
- Karnofsky or Lansky performance score ≥ 60 (ambulatory with or without assistive devices)
- For females of child-bearing age: not pregnant, negative serum pregnancy test within 7 days prior to enrollment, not lactating with intent to breastfeed
- Eligible for autologous apheresis or have a previously collected autologous apheresis product
- Adequate cardiac, renal, and pulmonary function as defined by study criteria
- Total bilirubin ≤ 3 times upper limit of normal except Gilbert's syndrome
- ALT or AST ≤ 5 times upper limit of normal
- Hemoglobin ≥ 7 g/dL (transfusions allowed)
- Platelet count ≥ 50,000/µL (transfusions allowed)
- Absolute neutrophil count ≥ 1000/µL
- Recovered from all grade III-IV non-hematologic acute toxicities from prior therapy
- If sexually active, agrees to use contraception until 3 months after T cell infusion
You will not qualify if you...
- Known primary immunodeficiency
- Known HIV positive status
- Severe, uncontrolled bacterial, viral, or fungal infection
- Known active malignancy other than the B7-H3 positive sarcoma being treated
- Rapidly progressive disease as assessed by investigators
- Presence of intracranial or spinal cord disease
- Medical conditions that could compromise health or interfere with study assessments
- Known severe hypersensitivity to corn starch or hydroxyethyl starch
- Receiving systemic steroid therapy exceeding 0.5 mg/kg/day methylprednisolone within 7 days prior to CAR T cell infusion
- Receiving systemic therapy within 14 days prior to protocol therapy that interferes with CAR T cell activity
- Radiation therapy within 4 weeks prior to protocol therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
Research Team
R
Rebecca Epperly, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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