NCT04044859

ADP-A2M4CD8 as Monotherapy or in Combination With Either Nivolumab or Pembrolizumab in HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS)

Active, enrolled Phase 1 Last updated 7 April 2026

What this trial tests

Phase 1 trial testing Autologous genetically modified ADP-A2M4CD8 cells alone or in combination with nivolumab every four weeks or pembrolizumab every 6 weeks in Endometrial Cancer in 120 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

20 August 2019

Primary endpoint
23 December 2026

30 April 2037

Quick facts

Lead sponsor	USWM CT, LLC
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	120
Start date	20 August 2019
Primary completion	23 December 2026
Estimated completion	30 April 2037
Sites	17 locations across Canada, United States, Spain

Drugs / interventions tested

• Autologous genetically modified ADP-A2M4CD8 cells alone or in combination with nivolumab every four weeks or pembrolizumab every 6 weeks

Conditions studied

• Endometrial Cancer — all drugs for Endometrial Cancer →
• Esophageal Cancer — all drugs for Esophageal Cancer →
• Esophagogastric Junction (EGJ) — all drugs for Esophagogastric Junction (EGJ) →
• Gastric (Stomach) Cancer — all drugs for Gastric (Stomach) Cancer →

Sponsor

USWM CT, LLC — full company profile →

Who can join

Adults 18 to 75, any sex, with Endometrial Cancer or Esophageal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cancer Therapy With TCR-Engineered T Cells: Current Strategies, Challenges, and Prospects.
   Shafer P, Kelly LM, Hoyos V. · · 2022 · cited 181× · PMID 35309357 · DOI 10.3389/fimmu.2022.835762
2. Autologous T cell therapy for MAGE-A4⁺ solid cancers in HLA-A*02⁺ patients: a phase 1 trial.
   Hong DS, Van Tine BA, Biswas S, McAlpine C, et al · · 2023 · cited 159× · PMID 36624315 · DOI 10.1038/s41591-022-02128-z
3. T-cell receptor-based therapy: an innovative therapeutic approach for solid tumors.
   Tsimberidou AM, Van Morris K, Vo HH, Eck S, et al · · 2021 · cited 119× · PMID 34193217 · DOI 10.1186/s13045-021-01115-0
4. Current Strategies and Novel Therapeutic Approaches for Metastatic Urothelial Carcinoma.
   Mollica V, Rizzo A, Montironi R, Cheng L, et al · · 2020 · cited 75× · PMID 32498352 · DOI 10.3390/cancers12061449
5. Biology of Cancer-Testis Antigens and Their Therapeutic Implications in Cancer.
   Nin DS, Deng LW. · · 2023 · cited 45× · PMID 36980267 · DOI 10.3390/cells12060926
6. Phase I clinical trial evaluating the safety and efficacy of ADP-A2M10 SPEAR T cells in patients with MAGE-A10⁺ advanced non-small cell lung cancer.
   Blumenschein GR, Devarakonda S, Johnson M, Moreno V, et al · · 2022 · cited 45× · PMID 35086946 · DOI 10.1136/jitc-2021-003581
7. The Melanoma-Associated Antigen Family A (MAGE-A): A Promising Target for Cancer Immunotherapy?
   Alsalloum A, Shevchenko JA, Sennikov S. · · 2023 · cited 39× · PMID 36980665 · DOI 10.3390/cancers15061779
8. Targeting cancer testis antigens in synovial sarcoma.
   Mitchell G, Pollack SM, Wagner MJ. · · 2021 · cited 27× · PMID 34083416 · DOI 10.1136/jitc-2020-002072