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

  • STATUS
    Recruiting
  • End date
    Apr 30, 2037
  • participants needed
    90
  • sponsor
    Adaptimmune
Updated on 14 June 2022
cancer
hla-a
measurable disease
carcinoma
leukapheresis
oximetry
esophageal cancer
gastric cancer
nivolumab
ovarian cancer
sarcoma
esophagus cancer
cancer of the ovary
lung carcinoma

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.

Description

Conditions

Endometrial Esophageal Cancer Esophagogastric Junction (EGJ) Gastric (stomach) Head and Neck Melanoma Non-small Cell Lung (NSCLC) Ovarian Cancer

Details
Condition Endometrial Cancer, Esophageal Cancer, Esophagogastric Junction (EGJ), Gastric (Stomach) Cancer, Head and Neck Cancer, Melanoma, Ovarian Cancer, Non-small Cell Lung (NSCLC), Urothelial Cancer
Treatment Autologous genetically modified ADP-A2M4CD8 cells, Autologous genetically modified ADP-A2M4CD8 cells alone or in combination with nivolumab every four weeks
Clinical Study IdentifierNCT04044859
SponsorAdaptimmune
Last Modified on14 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age ≥18 and ≤ 75 years
Subject is positive for at least 1 HLA-A02 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

Exclusion Criteria

Positive for any HLA-A02 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
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