Status:
ACTIVE_NOT_RECRUITING
ADP-A2M4CD8 as Monotherapy or in Combination With Either Nivolumab or Pembrolizumab in HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS)
Lead Sponsor:
Adaptimmune
Collaborating Sponsors:
ICON plc
Conditions:
Endometrial Cancer
Esophageal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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 in...
Detailed Description
Conditions: Endometrial Esophageal Cancer Esophagogastric Junction (EGJ) Gastric (stomach) Head and Neck Melanoma Non-small Cell Lung (NSCLC) Ovarian Cancer
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2037
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04044859
Start Date
August 20 2019
End Date
April 30 2037
Last Update
March 13 2025
Active Locations (17)
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1
Name of Institution: Orlando Health Cancer Institute
Orlando, Florida, United States, 32806
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
3
Washington University - School of Medicine
St Louis, Missouri, United States, 63110
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065