SPEARHEAD-3 Pediatric Study
Condition(s) studied
Investigational drug(s) / intervention(s)
Afamitresgene autoleucel: Single infusion of afamitresgene autoleucel Dose: For subjects ≥10 kg to \<40 kg: starting dose of 0.025 - 0.200 x 10'9 transduced cells/kg. For subjects ≥40 kg 1.0x109 to 10x109 transduced by a single intravenous infusion
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.
Eligibility
Primary outcome measure(s)
- Incidence, duration, and severity of Treatment Emergent Adverse Events as assessed by Investigator Evaluation. — 3.5 years
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)
Trial sites (10)
| Facility | City | Region | Status |
|---|---|---|---|
| Stanford University | Palo Alto | California | Recruiting |
| National Institutes of Health | Bethesda | Maryland | Recruiting |
| Dana Farber Cancer Institute | Boston | Massachusetts | Recruiting |
| Washington University | St Louis | Missouri | Recruiting |
| Memorial Sloan Kettering Kids | New York | New York | Recruiting |
| Duke University School of Medicine | Durham | North Carolina | Recruiting |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | Recruiting |
| Children's Hospital of Philedephia | Philadelphia | Pennsylvania | Recruiting |
| Seattle Children's Hospital | Seattle | Washington | Recruiting |
| University of Wisconsin Cancer Center | Madison | Wisconsin | Recruiting |
More USWM CT, LLC trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05642455 on ClinicalTrials.gov ↗ ← All trials in the USA