Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study 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) .
Eligibility
Primary outcome measure(s)
- Overall Response Rate (ORR) (Cohort 1) — From T-cell infusion until disease progression/recurrence as of data cut off (up to 2 years). Response was assessed at Week 4, Week 8, Week 12, Week 16, and Week 24, and every 2 months +/- 28 days until confirmed disease progression.
Percentage of participants with confirmed tumor response (complete \[CR\] or partial \[PR\] response) to treatment as assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Independent Radiologist review (Cohort 1)
Trial sites (26)
| Facility | City | Region | Status |
|---|---|---|---|
| City of Hope | Duarte | California | |
| Stanford Cancer Center | Palo Alto | California | |
| University of Colorado | Aurora | Colorado | |
| Mayo Clinic Jacksonville | Jacksonville | Florida | |
| Moffitt Cancer Center | Tampa | Florida | |
| Northwestern University Robert H. Lurie Comprehensive Cancer Center | Chicago | Illinois | |
| National Cancer Institute | Bethesda | Maryland | |
| Massachusetts General Hospital | Boston | Massachusetts | |
| Dana Farber Cancer Institute | Boston | Massachusetts | |
| University of Michigan | Ann Arbor | Michigan | |
| Washington University School of Medicine | St Louis | Missouri | |
| Memorial Sloan-Kettering Cancer Center | New York | New York | |
| Ohio State University | Columbus | Ohio | |
| Vanderbilt | Nashville | Tennessee | |
| MD Anderson Cancer Center | Houston | Texas | |
| Fred Hutch | Seattle | Washington | |
| Medical College of WI Froedtert Hospital | Milwaukee | Wisconsin | |
| Princess Margaret Cancer Centre | Toronto | Ontario | |
| Centre Leon Berard | Lyon | France | |
| Hospital Haut Leveque, CHU Bordeaux | Pessac | France | |
| Gustave Roussy Cancer Center | Villejuif | France | |
| Hospital Universitari Vall D'Hebron | Barcelona | Catalonia | |
| Start Madrid-FJD, Fundación Jimѐnez Díaz | Madrid | Spain | |
| Hospital Universitario Virgen del Rocio | Seville | Spain | |
| UCLH Cancer Clinical Trials Unit | London | United Kingdom | |
| The Christie NHS Foundation Trust | Manchester | United Kingdom |
More USWM CT, LLC trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04044768 on ClinicalTrials.gov ↗ ← All trials in the USA