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NCT05642455 · ClinicalTrials.gov registry record · Phase 1

SPEARHEAD-3 Pediatric Study

A Phase 1 study of Osteosarcoma and Synovial Sarcoma, sponsored by Uswm CT.

Recruiting
Registry status
Phase 1
Development phase
20
Enrollment target
10
Study locations

NCT05642455 is a Phase 1 study of Osteosarcoma and Synovial Sarcoma that is actively recruiting participants, run by Uswm CT. The registered enrollment target is 20 participants, below the 301-participant average among 46 other Osteosarcoma trials with a reported enrollment target (93% lower). The trial reports 10 study locations across 10 states.

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The verdict

NCT05642455, a Phase 1 study of Osteosarcoma and Synovial Sarcoma, is actively recruiting participants, sponsored by Uswm CT.

RECRUITING
Registry status
Phase 1
Development phase
20 participants
Enrollment target
10
Study locations

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.

Interventions

  • GENETIC Afamitresgene autoleucel

Study Locations (10)

California

  • Stanford University - Palo Alto

Maryland

  • National Institutes of Health - Bethesda

Massachusetts

  • Dana Farber Cancer Institute - Boston

Missouri

  • Washington University - St Louis

New York

  • Memorial Sloan Kettering Kids - New York

North Carolina

  • Duke University School of Medicine - Durham

Ohio

  • Cincinnati Children's Hospital Medical Center - Cincinnati

Pennsylvania

  • Children's Hospital of Philedephia - Philadelphia

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2023-09-01
Est. Completion 2038-07-30
Phase Phase 1

Sponsor

Uswm CT

7 total trials

What the Registry Record Tells You About NCT05642455

The ClinicalTrials.gov registry entry for NCT05642455 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 301-participant average among 46 other Osteosarcoma trials with a reported enrollment target (93% lower). The listed sponsor is Uswm CT, which has 7 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Osteosarcoma appearing as the primary indexed condition, and to 1 intervention - of which Afamitresgene autoleucel is the first listed.

NCT05642455 reports 10 study locations spanning 10 distinct geographic areas - top geographies include California, Maryland, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT05642455 about?

NCT05642455 is a clinical study titled "SPEARHEAD-3 Pediatric Study". 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.

What is the current status of trial NCT05642455?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2023-09-01. Estimated completion is 2038-07-30.

What conditions does trial NCT05642455 study?

This clinical trial studies the following conditions: Osteosarcoma, Synovial Sarcoma, Malignant Peripheral Nerve Sheath Tumor (MPNST), Neuroblastoma (NBL).

What interventions are being tested in trial NCT05642455?

The interventions under investigation include: Afamitresgene autoleucel (GENETIC).

Who is sponsoring clinical trial NCT05642455?

This trial is sponsored by Uswm CT, which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05642455 being conducted?

This trial has 10 study locations across California, Maryland, Massachusetts, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.