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)
1 other identifier
interventional
120
3 countries
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2019
Longer than P75 for phase_1
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 3, 2019
CompletedFirst Posted
Study publicly available on registry
August 5, 2019
CompletedStudy Start
First participant enrolled
August 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 23, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2037
ExpectedFebruary 9, 2026
February 1, 2026
6.7 years
July 3, 2019
February 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To evaluate safety and tolerability of ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab
Determination of incidence of dose-limiting toxicities, adverse events and tolerable dose
2.5 years
To evaluate safety of ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab
Incidence of patients with Replication-competent Retrovirus, persistence of ADP-A2M4CD8 T-cells and incidence of insertional oncogenesis.
Up to 15 years
Secondary Outcomes (7)
Anti-tumour activity: Overall Response Rate (ORR)
2.5 years
Anti-tumor activity: Best overall response (BOR)
2.5 years
Time to response (TTR)
2.5 years
Duration of Response (DOR)
2.5 years
Duration of stable disease (DoSD)
2.5 years
- +2 more secondary outcomes
Study Arms (1)
Autologous genetically modified ADP-A2M4CD8 cells
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- Age ≥18 and ≤ 75 years
- 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.
You may not qualify if:
- Subjects must have ≥ 90% room air oxygen saturation at rest at Screening (within 7 days of leukapheresis) and at Baseline.
- 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
- Pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- USWM CT, LLClead
Study Sites (17)
Name of Institution: Orlando Health Cancer Institute
Orlando, Florida, 32806, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Washington University - School of Medicine
St Louis, Missouri, 63110, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Duke University Medical Center, Duke Cancer Institute
Durham, North Carolina, 27710, United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Hospital Universitario 12 De Octubre
Madrid, Avenida de Cordoba S/n, 28041, Spain
Clinica Universitaria de Navarra
Pío, Pamplona, 31008, Spain
Hospital Clinico de Valencia
Ibanez, Valencia, 46010, Spain
Hospital Universitario Vall d'Hebron
Barcelona, 08035, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Universitario HM Sanchinarro CIOCC
Madrid, 28050, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Hong, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2019
First Posted
August 5, 2019
Study Start
August 20, 2019
Primary Completion
April 23, 2026
Study Completion (Estimated)
April 30, 2037
Last Updated
February 9, 2026
Record last verified: 2026-02