NCT05642455

SPEARHEAD-3 Pediatric Study

A Phase 1/2 Open Label, Basket Study to Assess the Safety, Tolerability and Anti-Tumor Activity of Afamitresgene Autoleucel in Pediatric Subjects With MAGE-A4 Positive Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: USWM CT, LLC · Industry
• Sex: All
• Age: 2 Years – 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Synovial Sarcoma
• Malignant Peripheral Nerve Sheath Tumor (MPNST)
• Neuroblastoma (NBL)
• Osteosarcoma

Interventions

Type	Name	Description
GENETIC	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

Timeline

• Start date: 2023-09-01
• Primary completion: 2026-10-01
• Completion: 2038-07-30
• First posted: 2022-12-08
• Last updated: 2026-02-09

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study