FGFR4 Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory Rhabdomyosarcoma

PHASE1RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

September 22, 2025

Primary Completion Date

December 1, 2027

Study Completion Date

April 1, 2029

Conditions
Rhabdomyosarcoma
Interventions
DRUG

fludarabine

30 mg/m2 per day IV on days -5, -4, -3, -2

DRUG

cyclophosphamide

500 mg/m2 per day IV on days -4, -3, -2

DRUG

cetuximab

"Participants Age \>=18 years, based on FDA approved dosing: Loading dose of 400 mg/m2 IV, followed by 250 mg/m2 IV weekly for a total of 4 doses.~Participants Age \<18 years, based on phase I data of cetuximab in children: Dose of 250 mg/m2 IV administered over 1 hour weekly for a total of 4 doses."

BIOLOGICAL

FGFR4-CAR T Cells

Single intravenous (IV) infusion on Day 0

Trial Locations (1)

20892

RECRUITING

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT06865664 - FGFR4 Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory Rhabdomyosarcoma | Biotech Hunter | Biotech Hunter