Hypofractionated Radiation with B7-H3-CAR T Cells for Pediatric Sarcomas
This study, called RAD3CAR, is testing a new combination treatment for children and young adults (up to 21 years old) with sarcomas that have come back or haven't responded to other treatments. It combines a special type of radiation therapy (hypofractionated radiation therapy) with B7-H3-CAR T cells. These CAR T cells are your own immune cells that have been specially trained to find and fight cancer cells that have a marker called B7-H3. Before receiving the CAR T cells, you would also receive chemotherapy (fludarabine and cyclophosphamide). The main goal is to see how safe this combination treatment is and what side effects might occur. To join, your sarcoma must show the B7-H3 marker. The study plans to enroll 42 participants.
- Study design
- This is a Phase I study, meaning it's focused on safety. It aims to enroll 42 participants.
- What's involved
- You would undergo apheresis to collect your immune cells, receive radiation therapy, chemotherapy (fludarabine and cyclophosphamide), and then the B7-H3-CAR T cell infusion. You will be evaluated for side effects for up to 4 weeks after the CAR T cell infusion.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be monitored for side effects for up to 4 weeks after the CAR T cell infusion.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07222735
Hypofractionated Radiation in Combination With B7-H3-CAR T Cells for Pediatric Patients With Relapsed/Refractory Sarcomas
Recruiting
PHASE1Up to 21InterventionalTreatmentSt. Jude Children's Research HospitalInvestigator-initiated
~42 participants
Updated 2026-02-09 on ClinicalTrials.gov
What's tested:FludarabineCyclophosphamideB7-H3-CAR T CellsRadiation Therapy
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose limiting toxicity (DLT) rate
Measured over up to 4 weeks after CAR T cell infusion
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesTennessee1
Study leadership
- Rebecca Epperly, MD · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Age ≤ 21 years old
B7-H3+ sarcoma; B7-H3 expression will be evaluated by standard immunohistochemistry (IHC) using any previously obtained biopsy; a tumor is considered B7-H3 positive with a H score greater than or equal to 100
Osteosarcoma
Ewing Sarcoma
Rhabdomyosarcoma Non-rhabdomyosarcoma soft tissue sarcomas
Evidence of relapsed (cancer that has completely responded \[i.e., no evidence of disease using standard imaging modalities\] to first-line therapy but has recurred for the first or subsequent time); or refractory (cancer that does not respond completely to treatment; cancer may be resistant at the beginning or may become resistant during treatment) disease after standard first-line therapy
Evaluable disease with presence of at least one lesion amenable to hypofractionated radiation therapy
For dose expansion cohort: participants must also have additional evaluable disease beyond planned radiation field
Estimated life expectancy of \> 12 weeks
Karnofsky or Lansky (age-dependent) performance score ≥ 60
Participants with mobility limitations due to prior surgical intervention (i.e., amputation) but who are up in wheelchair or with other assistive devices will be considered ambulatory for the purpose of performance score determination
For females of child-bearing age:
Not pregnant with negative serum pregnancy test within 7 days prior to enrollment
Not lactating with intent to breastfeed
Participants must be eligible to undergo autologous apheresis or have an available previously collected autologous apheresis product
Age ≤ 21 years old at the time of manufacturing
B7-H3+ sarcoma
Evidence of relapsed or refractory disease after standard first-line therapy
Evaluable disease with the presence of at least one lesion amenable to hypofractionated radiation therapy
Estimated life expectancy of \> 8 weeks
Karnofsky or Lansky (age-dependent) performance score ≥ 60
Adequate cardiac function defined by echocardiogram with left ventricular ejection fraction ≥ 50%
Adequate renal function as defined by not exceeding the maximum serum creatinine listed below by age:
1 to \<2 years: 0.6
2 to \<6 years: 0.8
6 to \<10 years: 1
10 to \<13 years: 1.2
13 to \<16 years: male 1.5, female 1.4
≥ 16 years: male 1.7, female 1.4
Adequate pulmonary function defined as pulse oximetry ≥ 92% on room air
Total Bilirubin ≤3 times the upper limit of normal for age, except in subjects with Gilbert's syndrome
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤5 times the upper limit of normal for age
Hemoglobin ≥ 7g/dL (can be transfused)
Platelet count ≥ 50,000/μL (can be transfused)
Absolute neutrophil count (ANC) ≥ 1000/μL
Has recovered from all NCI CTAE grade III-IV, non-hematologic acute toxicities from prior therapy
For females of child-bearing age:
Not pregnant with negative serum pregnancy test within 7 days prior to enrollment
Not lactating with intent to breastfeed
If sexually active, agreement to use contraception until 3 months after T cell infusion
Exclusion
Known primary immunodeficiency
Known HIV positivity
Severe, uncontrolled intercurrent bacterial, viral, or fungal infection
Known active malignancy other than the B7-H3+ sarcoma being treated on study
Rapidly progressive disease (as assessed by the study PIs, with consideration for proximity to critical structures)
Presence of intracranial or spinal cord disease
Known underlying medical condition(s) for which, in the investigator's opinion, participation in this trial would not be in the best interest of the participant (e.g., compromises the health of the subject) or that could prevent, limit, or confound protocol assessments
Known severe hypersensitivity to corn starch or hydroxyethyl starch
Known primary immunodeficiency
Known HIV positivity
Severe, uncontrolled intercurrent bacterial, viral, or fungal infection
Known active malignancy other than the B7-H3+ sarcoma being treated on study
Receiving systemic steroid therapy exceeding the equivalent of 0.5 mg/kg/day of methylprednisolone, \< 7 days prior to CAR T cell infusion
Receiving systemic therapy \< 14 days prior to start of protocol therapy, which will interfere with the activity of the CAR product (in the opinion of the study PIs)
Received radiation therapy within the 4 weeks prior to start of protocol therapy
Rapidly progressive disease (as assessed by the study PIs, with consideration for proximity to critical structures)
Presence of intracranial or spinal cord disease
Known underlying medical condition(s) for which, in the investigator's opinion, participation in this trial would not be in the best interest of the participant (e.g., compromises the health of the subject) or that could prevent, limit, or confound protocol assessments
Known severe hypersensitivity to corn starch or hydroxyethyl starch
What this trial measures
- Dose limiting toxicity (DLT) rateup to 4 weeks after CAR T cell infusion
Proportion of evaluable participants experiencing DLTs
- Incidence of adverse events (AEs)up to 4 weeks after CAR T cell infusion
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