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

NCT07222735 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-02-09

No results posted yet for this study

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

Conditions

  • Sarcoma
  • Childhood Osteosarcoma
  • Childhood Rhabdomyosarcoma
  • Childhood Soft Tissue Sarcoma
  • Ewing Sarcoma

Interventions

DRUG

Fludarabine

Intravenously on day -5, -4, -3 and -2

DRUG

Cyclophosphamide

Intravenously on day -3, -2

DRUG

B7-H3-CAR T Cells

Intravenously on day 0

RADIATION

Radiation Therapy

5 or 8 treatment sessions (fractions), scheduled to complete on Day -2

Sponsors & Collaborators

Principal Investigators

  • Rebecca Epperly, MD · St. Jude Children's Research Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-21
Primary Completion
2030-11-05
Completion
2031-11-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07222735 on ClinicalTrials.gov