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Active, not recruiting Phase 1

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

NCT04044859 · tracked via the Priya Life Science USA tracker
Phase
Phase 1
Started
2019-08-20
Last updated
2026-09-23

Condition(s) studied

Endometrial CancerEsophageal CancerEsophagogastric Junction (EGJ)Gastric (Stomach) CancerHead and Neck CancerMelanomaOvarian CancerNon-small Cell Lung (NSCLC)Urothelial Cancer

Investigational drug(s) / intervention(s)

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

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
* 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. Key exclusion criteria * Positive for any HLA-A\*02 allele other than: one of the inclusion alleles * 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 Note: other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcome measure(s)

  • To evaluate safety and tolerability of ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab — 2.5 years
    Determination of incidence of dose-limiting toxicities, adverse events and tolerable dose
  • To evaluate safety of ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab — Up to 15 years
    Incidence of patients with Replication-competent Retrovirus, persistence of ADP-A2M4CD8 T-cells and incidence of insertional oncogenesis.

Trial sites (17)

FacilityCityRegionStatus
Name of Institution: Orlando Health Cancer Institute Orlando Florida
Massachusetts General Hospital Boston Massachusetts
Washington University - School of Medicine St Louis Missouri
Memorial Sloan Kettering Cancer Center New York New York
Duke University Medical Center, Duke Cancer Institute Durham North Carolina
OU Health Stephenson Cancer Center Oklahoma City Oklahoma
Sarah Cannon Research Institute Nashville Tennessee
M.D. Anderson Cancer Center Houston Texas
Froedtert Hospital and the Medical College of Wisconsin Milwaukee Wisconsin
Princess Margaret Cancer Centre Toronto Ontario
Hospital Universitario 12 De Octubre Madrid Avenida de Cordoba S/n
Clinica Universitaria de Navarra Pío Pamplona
Hospital Clinico de Valencia Ibanez Valencia
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04044859 on ClinicalTrials.gov ↗ ← All trials in the USA