NCT04044859Active, not recruitingPhase 1
ADP-A2M4CD8 as Monotherapy or in Combination With Either Nivolumab or Pembrolizumab in HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS)
A Phase 1 Dose Escalation Study To Assess Safety And Efficacy Of ADP-A2M4CD8 As Monotherapy Or In Combination With Either Nivolumab Or Pembrolizumab In HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS)
Source: ClinicalTrials.gov · Last updated 23 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 3 Jul 2019
- Start date
- 20 Aug 2019
- Primary completion date
- 15 Apr 2026
- Lead sponsor
- USWM CT, LLC
- Diseases
- Head and neck cancer, Bladder cancer, Melanoma, Endometrial cancer, Lung cancer, Gastric and esophageal cancer, Ovarian cancer
- NCT number
- NCT04044859
- EU CT number
- 2024-512864-71-00
- EudraCT number
- 2019-001965-34
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 120
- From 20 Aug 2019 to the primary completion date, 15 Apr 2026
- 13 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study
- Active autoimmune or immune mediated disease
- Leptomeningeal disease, carcinomatous meningitis or symptomatic CNS metastases
- Other prior malignancy that is not considered by the Investigator to be in complete remission. Clinically significant cardiovascular disease
- Uncontrolled intercurrent illness
- Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or human T cell leukemia virus
Other
- Positive for any HLA-A\*02 allele other than: one of the inclusion alleles
- Pregnant or breastfeeding
- Note: other protocol defined Inclusion/Exclusion criteria may apply.
Criteria the registry did not label
- Key Inclusion criteria
- Age ≥18 and ≤ 75 years
- Subject is positive for at least 1 HLA-A\*02 inclusion allele
- Histologically or cytogenetically confirmed diagnosis of urothelial cancer, esophageal, esophagogastric junction (EGJ) cancer, gastric cancer, non-small cell lung carcinoma (NSCLC), head and neck or ovarian cancer, endometrial cancer, melanoma
- Measurable disease according to RECIST v1.1 prior to leukapheresis and lymphodepletion.
- Tumor shows MAGE-A4 expression as confirmed by central laboratory
- ECOG Performance Status of 0 or 1.
- Left ventricular ejection fraction (LVEF) ≥50% or the institutional lower limit of normal range, whichever is lower Note: other protocol defined Inclusion/Exclusion criteria may apply
- Subjects must have ≥ 90% room air oxygen saturation at rest at Screening (within 7 days of leukapheresis) and at Baseline.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario HM Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Duke University Medical Center, Duke Cancer Institute Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Froedtert Hospital and the Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Sarah Cannon Research Institute Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| OU Health Stephenson Cancer Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| Name of Institution: Orlando Health Cancer Institute Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.