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NCT05642455 · ClinicalTrials.gov registry record · Phase 1
SPEARHEAD-3 Pediatric Study
A Phase 1 study of Osteosarcoma and Synovial Sarcoma, sponsored by Uswm CT.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 10
- Study locations
NCT05642455: Recruiting Phase 1 study of Osteosarcoma and Synovial Sarcoma, sponsored by Uswm CT.
NCT05642455 is a Phase 1 study of Osteosarcoma and Synovial Sarcoma that is actively recruiting participants, run by Uswm CT. The registered enrollment target is 20 participants, below the 301-participant average among 46 other Osteosarcoma trials with a reported enrollment target (93% lower). The trial reports 10 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05642455, a Phase 1 study of Osteosarcoma and Synovial Sarcoma, is actively recruiting participants, sponsored by Uswm CT.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 10
- Study locations
Study Summary
This is a pediatric basket study to investigate the safety and efficacy of afamitresgene autoleucel in HLA-A\*02 eligible and MAGE-A4 positive subjects aged 2-17 years of age with advanced cancers.
Primary Outcome
Determination of incidence, severity and duration of adverse events * Incidence of dose limiting toxicities DLTs * AEs including serious adverse events (SAEs) * Incidence, severity, and duration of the AEs of special interest * Replication competent lentivirus (RCL) * T-cell clonality and insertional oncogenesis (IO)
Conditions Studied
Interventions
- GENETIC Afamitresgene autoleucel
Study Locations (10)
California
- Stanford University - Palo Alto
Maryland
- National Institutes of Health - Bethesda
Massachusetts
- Dana Farber Cancer Institute - Boston
Missouri
- Washington University - St Louis
New York
- Memorial Sloan Kettering Kids - New York
North Carolina
- Duke University School of Medicine - Durham
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Pennsylvania
- Children's Hospital of Philedephia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-09-01 |
| Est. Completion | 2038-07-30 |
| Phase | Phase 1 |
What NCT05642455 shows while recruiting
NCT05642455 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 301-participant average among 46 other Osteosarcoma trials with a reported enrollment target (93% lower).
The record links to 4 conditions, with Osteosarcoma appearing as the primary indexed condition, and to 1 intervention - of which Afamitresgene autoleucel is the first listed.
NCT05642455 lists 10 locations in 10 states (California, Maryland, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT05642455 about?
NCT05642455 is a clinical study titled "SPEARHEAD-3 Pediatric Study". This is a pediatric basket study to investigate the safety and efficacy of afamitresgene autoleucel in HLA-A\*02 eligible and MAGE-A4 positive subjects aged 2-17 years of age with advanced cancers.
What is the current status of trial NCT05642455?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2023-09-01. Estimated completion is 2038-07-30.
What conditions does trial NCT05642455 study?
This clinical trial studies the following conditions: Osteosarcoma, Synovial Sarcoma, Malignant Peripheral Nerve Sheath Tumor (MPNST), Neuroblastoma (NBL).
What interventions are being tested in trial NCT05642455?
The interventions under investigation include: Afamitresgene autoleucel (GENETIC).
Who is sponsoring clinical trial NCT05642455?
This trial is sponsored by Uswm CT, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05642455 being conducted?
This trial has 10 study locations across California, Maryland, Massachusetts, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Osteosarcoma
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 NCT05642455's enrollment target sits among peer trials
20 37th of 46 higher than 10 of 46 other Osteosarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteosarcoma 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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