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RECRUITING
NCT05642455
PHASE1/PHASE2

SPEARHEAD-3 Pediatric Study

Sponsor: USWM CT, LLC

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

2 Years - 21 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2023-09-01

Completion Date

2038-07-30

Last Updated

2026-02-09

Healthy Volunteers

No

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

Locations (10)

Stanford University

Palo Alto, California, United States

National Institutes of Health

Bethesda, Maryland, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Washington University

St Louis, Missouri, United States

Memorial Sloan Kettering Kids

New York, New York, United States

Duke University School of Medicine

Durham, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Children's Hospital of Philedephia

Philadelphia, Pennsylvania, United States

Seattle Children's Hospital

Seattle, Washington, United States

University of Wisconsin Cancer Center

Madison, Wisconsin, United States