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SPEARHEAD-3 Pediatric Study

NCT05642455 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-02-09

No results posted yet for this 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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • USWM CT, LLC

    lead INDUSTRY

Principal Investigators

  • Fiorella Iglesias Cardenas, MD · Memorial Sloan Kettering Kids

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2026-10-01
Completion
2038-07-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05642455 on ClinicalTrials.gov