drugset / Trial / NCT05642455

SPEARHEAD-3 Pediatric Study

NCT05642455 ↗

Phase 1/2 Recruiting 20 enrolled USWM CT, LLC
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2023-09-01
Primary completion
2026-10-01
Completion
2038-07-30

Drugs

EvaluationDrugModalityDoseRoute
Subject afamitresgene autoleucel Cell therapy 2.5e+07 cells/kg Intravenous
Subject afamitresgene autoleucel Cell therapy 2e+08 cells/kg Intravenous
Subject afamitresgene autoleucel Cell therapy 1e+09 cells Intravenous
Subject afamitresgene autoleucel Cell therapy 1e+10 cells Intravenous