ADP-A2M4CD8 as Monotherapy or in Combination With Either Nivolumab or Pembrolizumab in HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS)
Condition(s) studied
Investigational drug(s) / intervention(s)
Autologous genetically modified ADP-A2M4CD8 cells alone or in combination with nivolumab every four weeks or pembrolizumab every 6 weeks: Infusion 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 summary
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.
Eligibility
Primary outcome measure(s)
- To evaluate safety and tolerability of ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab — 2.5 years
Determination of incidence of dose-limiting toxicities, adverse events and tolerable dose - To evaluate safety of ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab — Up to 15 years
Incidence of patients with Replication-competent Retrovirus, persistence of ADP-A2M4CD8 T-cells and incidence of insertional oncogenesis.
Trial sites (17)
| Facility | City | Region | Status |
|---|---|---|---|
| Name of Institution: Orlando Health Cancer Institute | Orlando | Florida | |
| Massachusetts General Hospital | Boston | Massachusetts | |
| Washington University - School of Medicine | St Louis | Missouri | |
| Memorial Sloan Kettering Cancer Center | New York | New York | |
| Duke University Medical Center, Duke Cancer Institute | Durham | North Carolina | |
| OU Health Stephenson Cancer Center | Oklahoma City | Oklahoma | |
| Sarah Cannon Research Institute | Nashville | Tennessee | |
| M.D. Anderson Cancer Center | Houston | Texas | |
| Froedtert Hospital and the Medical College of Wisconsin | Milwaukee | Wisconsin | |
| Princess Margaret Cancer Centre | Toronto | Ontario | |
| Hospital Universitario 12 De Octubre | Madrid | Avenida de Cordoba S/n | |
| Clinica Universitaria de Navarra | Pío | Pamplona | |
| Hospital Clinico de Valencia | Ibanez | Valencia | |
| Hospital Universitario Vall d'Hebron | Barcelona | Spain | |
| Hospital Universitario Fundacion Jimenez Diaz | Madrid | Spain | |
| Hospital Universitario HM Sanchinarro CIOCC | Madrid | Spain | |
| Hospital Universitario Virgen del Rocio | Seville | Spain |
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 NCT04044859 on ClinicalTrials.gov ↗ ← All trials in the USA