ADP-A2M4CD8 as Monotherapy or in Combination With Either Nivolumab or Pembrolizumab in HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS)
NCT04044859 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2026-04-07
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.
Conditions
- Endometrial Cancer
- Esophageal Cancer
- Esophagogastric Junction (EGJ)
- Gastric (Stomach) Cancer
- Head and Neck Cancer
- Melanoma
- Ovarian Cancer
- Non-small Cell Lung (NSCLC)
- Urothelial Cancer
Interventions
- GENETIC
-
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
Sponsors & Collaborators
-
USWM CT, LLC
lead INDUSTRY
Principal Investigators
-
David Hong, MD · M.D. Anderson Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-08-20
- Primary Completion
- 2026-12-23
- Completion
- 2037-04-30
- FDA Drug
- Yes
Countries
- United States
- Canada
- Spain
Study Locations
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