MedTrace Logo

Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma

NCT04044768 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2026-02-06

Study results available
· View outcomes & findings →

Summary

This is a study to investigate the efficacy and safety of ADP-A2M4 in HLA-A\*02 eligible and MAGE-A4 positive subjects with metastatic or inoperable (advanced) Synovial Sarcoma (Cohort 1, 2 and 3 ) or MRCLS (Cohort 1) .

Conditions

  • Synovial Sarcoma
  • Myxoid Liposarcoma

Interventions

GENETIC

afamitresgene autoleucel (previously ADP-A2M4)

Single infusion of autologous genetically modified afamitresgene autoleucel (previously ADP-A2M4) Dose: 1.0 x109 to 10x109 transduced by a single intravenous infusion

Sponsors & Collaborators

  • USWM CT, LLC

    lead INDUSTRY

Principal Investigators

  • Dejka Araujo, MD · MD Anderson Cancer Center; Houston TX 77030

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-13
Primary Completion
2021-08-29
Completion
2038-04-01
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Spain
  • United Kingdom

Study Locations

More Related Trials

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 NCT04044768 on ClinicalTrials.gov