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

Official record

Identifier

NCT04044859

Recruiting locations

countries

United StatesCanadaSpain

Interventions studied

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

Lead sponsor

USWM CT, LLC

Target enrolment

120 participants

Study type

INTERVENTIONAL

Phase

Phase 1

Status

Active, not recruiting

First posted

Aug 5, 2019

Last updated on the registry

Sep 23, 2026

Age

18 Years – 75 Years

Sex

ALL

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

* 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.

Indexed under

Gastric Cancer