OncoMatch/Clinical Trials/NCT06865664
FGFR4 Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory Rhabdomyosarcoma
Is NCT06865664 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including FGFR4-CAR T Cells and fludarabine for rhabdomyosarcoma.
Treatment: fludarabine · cyclophosphamide · cetuximab · FGFR4-CAR T Cells — Background: Rhabdomyosarcoma (RMS) is a cancer of soft tissues. It is the most common soft tissue sarcoma seen in children. RMS cancer cells have a protein called FGFR4 on their surface. Researchers want to try a new kind of treatment for RMS: They will collect a person s own T cells, a type of immune cell; then they will change the T cells so they are better able to target the FGFR4 protein and attack RMS tumor cells. The modified T cells are chimeric antigen receptor (CAR) T cells. The treatment in this study is called FGFR4-CAR T cells. Objective: To test FGFR4-CAR T cells in children and young adults with RMS. Eligibility: People aged 3 to 39 years with RMS. The RMS must have failed to respond or returned after at least 2 rounds of standard treatment. Design: Participants will be screened. They will have physical exam, imaging scans, blood tests, and tests of their heart. They may have a tissue sample taken from their tumor. They will undergo apheresis: Blood will be taken from the body through a catheter. The blood will pass through a machine that separates out the T cells, and the remaining blood will be returned to the body. The collected T cells will be taken to a lab to create FGFR4-CAR T cells. Once the FGFR4-CART cells are ready, participants can receive these T cells. For 4 days they will receive drugs to prepare their body for the FGFR4-CAR T cells. After this, the modified T cells will be infused into a vein. Participants will be then monitored closely to watch for any side effects from the CART cells and be followed to see what effect the CART cells have on their tumors. They will have follow-up visits for up to 5 years. Long-term follow-up will be another 10 years.
Check if I qualifyExtracted eligibility criteria
Cancer type
Rhabdomyosarcoma
Biomarker criteria
Allowed: FGFR4 expression (universal in rhabdomyosarcoma; confirmation not required)
Since FGFR4 expression is universal in rhabdomyosarcoma, confirmation of FGFR4 expression is not required.
Prior therapy
Must have received: systemic chemotherapy — upfront
relapsed or progressed after upfront therapy (that includes any systemic chemotherapy with or without local control)
Must have received: salvage therapy — salvage
at least one salvage therapy (which can be systemic therapy, radiation, or surgery)
Cannot have received: tyrosine kinase inhibitor, targeted agent, or metronomic non-myelosuppressive regimen
tyrosine kinase inhibitor, targeted agent, or metronomic non-myelosuppressive regimen within ≤ 1 week prior to apheresis
Cannot have received: systemic chemotherapy
systemic chemotherapy within ≤ 2 weeks prior to apheresis
Cannot have received: antineoplastic antibody therapy, checkpoint inhibitors, or vaccine therapy
antineoplastic antibody therapy, checkpoint inhibitors, or vaccine therapy, within ≤ 3 weeks or 5 half-lives (whichever is shorter) prior to apheresis
Cannot have received: radiation therapy
Exception: no time restriction if volume of bone marrow treated is <10% and participant has measurable/evaluable disease outside the radiation port
radiation within ≤ 3 weeks (≤ 6 weeks if CNS or lung fields have been radiated or in case of craniospinal irradiation or radiation of ≥50% of bony pelvis and ≤12 weeks in case of total body irradiation)
Cannot have received: investigational agent
any investigational agents within ≤ 4 weeks prior to apheresis
Cannot have received: autologous stem cell infusion following myeloablative therapy
autologous stem cell infusion following myeloablative therapy within ≤ 6 weeks prior to apheresis
Cannot have received: genetically modified T cell, NK cell, or dendritic cell therapy
genetically modified T cell, NK cell, or dendritic cell therapy within ≤ 6 weeks prior to apheresis
Cannot have received: allogeneic stem cell transplant/infusion
allogeneic stem cell transplant/infusion within ≤12 weeks or evidence of active graft versus host disease (GVHD)
Lab requirements
Blood counts
ANC ≥ 500/mcL; platelets ≥ 50,000/mcL (transfusion independent for those without bone marrow involvement); not refractory to transfusions
Kidney function
Serum creatinine thresholds by age/sex OR creatinine clearance/GFR ≥ 60 mL/min/1.73 m^2
Liver function
AST/ALT ≤ 5 x ULN; total bilirubin ≤ 2 x ULN (≤ 5 x ULN if Gilbert's syndrome or tumor involvement); adult values used for eligibility
Cardiac function
Ejection fraction ≥ 45% or shortening fraction ≥ 28%, pericardial effusion ≤ grade 2 by ECHO
Adequate organ and marrow function as defined below: ... see full criteria for details
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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