ADP-A2M4CD8 Monotherapy and in Combination With Nivolumab in HLA-A2+ Subjects With MAGE-A4 Positive Ovarian Cancer (SURPASS-3)
Part of paid clinical trials in Scottsdale, Arizona.
- Sponsor
- USWM CT, LLC
- Study ID
- NCT05601752
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Autologous genetically modified ADP-A2M4CD8 cells — GENETICInfusion of autologous genetically modified ADP-A2M4CD8 cells on Day 1
- Autologous genetically modified ADP-A2M4CD8 cells in combination with Nivolumab — COMBINATION_PRODUCTInfusion of autologous genetically modified ADP-A2M4CD8 on Day 1 followed by nivolumab 480 mg IV at Week 4 and then every four weeks
Study Details
This is a phase 2, open-label, randomized, non-comparative clinical trial to evaluate the clinical outcome of ADP A2M4CD8 as monotherapy and in combination treatment with nivolumab in human leukocyte antigen (HLA) A2+ subjects with recurrent ovarian cancer positive for MAGE-A4.
Key Dates
- Start date
- Jun 26, 2023
- Status verified
- Feb 2026
- Primary completion
- Aug 12, 2026
- Completion
- Aug 12, 2026
Study Design
- Enrollment
- 66 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Autologous genetically modified ADP-A2M4CD8 cells
- Experimental: Autologous genetically modified ADP-A2M4CD8 cells in combination with Nivolumab
Primary Outcome Measure
To evaluate the anti-tumor activity of genetically modified autologous T-cells (ADP-A2M4CD8) as monotherapy and in combination with nivolumab in HLA-A*02 positive subjects with MAGE-A4 positive recurrent ovarian cancer [ Time Frame: 3.6 years ]
Locations (9)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Honor Health | Scottsdale | Arizona | 85258 | - |
| City of Hope | Duarte | California | 91010 | - |
| Augusta University | Augusta | Georgia | 30912 | - |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | - |
| Rutgers Cancer Institute of NJ | New Brunswick | New Jersey | 08901 | - |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | - |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | - |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | - |
| Swedish Cancer Institute | Seattle | Washington | 98104 | - |
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