ADP-A2M4CD8 as Monotherapy or in Combination With Either Nivolumab or Pembrolizumab in HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS)
Part of paid clinical trials in Orlando, Florida.
- Sponsor
- USWM CT, LLC
- Study ID
- NCT04044859
- Phase
- PHASE1
- Status
- Active Not Recruiting
Conditions
- Endometrial Cancer
- Esophageal Cancer
- Esophagogastric Junction (EGJ)
- Gastric (Stomach) Cancer
- Head and Neck Cancer
- Melanoma
- Non-small Cell Lung (NSCLC)
- Ovarian Cancer
- Urothelial Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Autologous genetically modified ADP-A2M4CD8 cells alone or in combination with nivolumab every four weeks or pembrolizumab every 6 weeks — GENETICInfusion of autologous genetically modified ADP-A2M4CD8 on Day 1 alone or in combination with either nivolumab 480 mg IV every four weeks or pembrolizumab 400mg IV every 6 weeks
Study Details
This study will investigate the safety and tolerability of ADP-A2M4CD8 T-cell therapy in subjects who have the appropriate human leukocyte antigen (HLA) and MAGE-A4 tumor antigen. Tumor indications include endometrial, esophageal, esophagogastric junction (EGJ), gastric, head and neck, melanoma, non-small cell lung (NSCLC), ovarian or urothelial cancer.
Key Dates
- Start date
- Aug 20, 2019
- Status verified
- Apr 2026
- Primary completion
- Dec 23, 2026
- Completion
- Apr 30, 2037
Study Design
- Enrollment
- 120 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Autologous genetically modified ADP-A2M4CD8 cells
Primary Outcome Measure
To evaluate safety and tolerability of ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab [ Time Frame: 2.5 years ]
Locations (9)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Name of Institution: Orlando Health Cancer Institute | Orlando | Florida | 32806 | - |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | - |
| Washington University - School of Medicine | St Louis | Missouri | 63110 | - |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | - |
| Duke University Medical Center, Duke Cancer Institute | Durham | North Carolina | 27710 | - |
| OU Health Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | - |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | - |
| M.D. Anderson Cancer Center | Houston | Texas | 77030 | - |
| Froedtert Hospital and the Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | - |
Find similar trials in Orlando, FL
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Name of Institution: Orlando Health Cancer Institute· Orlando, FLMassachusetts General Hospital· Boston, MAWashington University - School of Medicine· St Louis, MOMemorial Sloan Kettering Cancer Center· New York, NYDuke University Medical Center, Duke Cancer Institute· Durham, NCOU Health Stephenson Cancer Center· Oklahoma City, OK
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