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NCT06865664 · ClinicalTrials.gov registry record · Phase 1
FGFR4 Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory Rhabdomyosarcoma
A Phase 1 study of Rhabdomyosarcoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT06865664: Recruiting Phase 1 study of Rhabdomyosarcoma, sponsored by National Cancer Institute (NCI).
NCT06865664 is a Phase 1 study of Rhabdomyosarcoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 50 participants, below the 68-participant average among 35 other Rhabdomyosarcoma trials with a reported enrollment target (26% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06865664, a Phase 1 study of Rhabdomyosarcoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Estimation of MTD using evaluation of adverse events considered to be a DLT within DLT period as explained in sections Dose Limiting Toxicity (DLT) and Dose Escalation (Arm 1)
Conditions Studied
Interventions
- DRUG cetuximab
- DRUG fludarabine
- DRUG cyclophosphamide
- BIOLOGICAL FGFR4-CAR T Cells
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2025-09-22 |
| Est. Completion | 2029-04-01 |
| Phase | Phase 1 |
What NCT06865664 shows while recruiting
NCT06865664 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 68-participant average among 35 other Rhabdomyosarcoma trials with a reported enrollment target (26% lower).
The record links to 1 condition, with Rhabdomyosarcoma appearing as the primary indexed condition, and to 4 interventions - of which cetuximab is the first listed.
NCT06865664 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06865664 about?
NCT06865664 is a clinical study titled "FGFR4 Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory Rhabdomyosarcoma". 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 imm...
What is the current status of trial NCT06865664?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2025-09-22. Estimated completion is 2029-04-01.
What conditions does trial NCT06865664 study?
This clinical trial studies the following conditions: Rhabdomyosarcoma.
What interventions are being tested in trial NCT06865664?
The interventions under investigation include: cetuximab (DRUG), fludarabine (DRUG), cyclophosphamide (DRUG), FGFR4-CAR T Cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT06865664?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06865664 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Rhabdomyosarcoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06865664's enrollment target sits among peer trials
50 12th of 35 higher than 24 of 35 other Rhabdomyosarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rhabdomyosarcoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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