RecruitingPhase 1Phase 2NCT05642455

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

Sponsor

USWM CT, LLC

Enrollment

20 participants

Start Date

Sep 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 2 YearsMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an experimental immune cell therapy called afami-cel (engineered T-cells targeting MAGE-A4, a protein found on certain tumors) in children and young adults with hard-to-treat solid tumors including synovial sarcoma, malignant peripheral nerve sheath tumor (MPNST), neuroblastoma, and osteosarcoma. **You may be eligible if...** - You have a confirmed diagnosis of synovial sarcoma (ages 2–17), MPNST, neuroblastoma, or osteosarcoma (ages 2–21) - You weigh at least 10 kg - Your tumor tests positive for MAGE-A4 protein (confirmed by a central lab) - You have the genetic marker HLA-A*02 - You have received at least one prior chemotherapy treatment - Your cancer is measurable on imaging and you are in good enough health to participate **You may NOT be eligible if...** - Your tumor does not express MAGE-A4 - You do not have the HLA-A*02 marker - Your general health or organ function is too poor - Your expected survival is less than 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

GENETICAfamitresgene 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