Loading clinical trials...

Hypofractionated Radiation in Combination With B7-H3-CAR T Cells for Pediatric Patients With Relapsed/Refractory Sarcomas | Clinical Trials | Clareo Health

RECRUITINGPHASE1

Hypofractionated Radiation in Combination With B7-H3-CAR T Cells for Pediatric Patients With Relapsed/Refractory Sarcomas

NCT07222735•St. Jude Children's Research Hospital

View on ClinicalTrials.gov

Summary

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

Detailed Description

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.

Eligibility

Age

0 - 21 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•\*a previously collected, autologous leukapheresis product can be used for T cell production
•Collection and manufacturing eligibility
•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
+35 more criteria

Exclusion Criteria

•Collection and manufacturing eligibility
•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
•Treatment eligibility
+11 more criteria

Locations (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Key Dates

Start Date

January 21, 2026

Primary Completion Date

November 5, 2030

Completion Date

November 5, 2031

Last Updated

February 9, 2026

Enrollment

ESTIMATED participants

Conditions

SarcomaChildhood OsteosarcomaChildhood RhabdomyosarcomaChildhood Soft Tissue SarcomaEwing Sarcoma

Interventions

Fludarabine

DRUG

Cyclophosphamide

DRUG

B7-H3-CAR T Cells

DRUG

Radiation Therapy

RADIATION

Contacts

Rebecca Epperly, MD

CONTACT

8662785833 referralinfo@stjude.org

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

NCT06066138

Locally Advanced Alveolar Soft Part SarcomaMetastatic Alveolar Soft Part Sarcoma+8 more

View study

RECRUITINGPHASE1

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

NCT05039801

Advanced Endometrial CarcinomaAdvanced Head and Neck Squamous Cell Carcinoma+36 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Hypofractionated Radiation in Combination With B7-H3-CAR T Cells for Pediatric Patients With Relapsed/Refractory Sarcomas

Inclusion Criteria

Exclusion Criteria

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Apatinib Combined With Liposomal Irinotecan for Refractory or Metastatic Osteosarcoma

Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas

Actinium Therapy for Late-stage Aggressive Sarcomas