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ACTIVE NOT RECRUITING
NCT04044859
PHASE1

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

Sponsor: USWM CT, LLC

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2019-08-20

Completion Date

2037-04-30

Last Updated

2026-04-07

Healthy Volunteers

No

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

Locations (17)

Name of Institution: Orlando Health Cancer Institute

Orlando, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Washington University - School of Medicine

St Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Duke University Medical Center, Duke Cancer Institute

Durham, North Carolina, United States

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

M.D. Anderson Cancer Center

Houston, Texas, United States

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Hospital Universitario 12 De Octubre

Madrid, Avenida de Cordoba S/n, Spain

Clinica Universitaria de Navarra

Pío, Pamplona, Spain

Hospital Clinico de Valencia

Ibanez, Valencia, Spain

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