ADP-A2M4CD8 as Monotherapy or in Combination With Either Nivolumab or Pembrolizumab in HLA-A2+ Su… (NCT04044859) | Clinical Trial Compass
Active — Not RecruitingPhase 1
ADP-A2M4CD8 as Monotherapy or in Combination With Either Nivolumab or Pembrolizumab in HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS)
United States120 participantsStarted 2019-08-20
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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, hepa…
What they're measuring
1
To evaluate safety and tolerability of ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab
Timeframe: 2.5 years
2
To evaluate safety of ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab