Trials / Active Not Recruiting
Active Not RecruitingNCT04044768
Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma
A Phase 2 Single Arm Open-Label Clinical Trial of ADP-A2M4 SPEAR™ T Cells in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- USWM CT, LLC · Industry
- Sex
- All
- Age
- 10 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2019-08-13
- Primary completion
- 2021-08-29
- Completion
- 2038-04-01
- First posted
- 2019-08-05
- Last updated
- 2026-02-06
- Results posted
- 2025-01-13
Locations
26 sites across 5 countries: United States, Canada, France, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04044768. Inclusion in this directory is not an endorsement.