Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Autologous genetically modified ADP-A2M4CD8 cells
  • Genetic: 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

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Donald P Lawrence
617-643-3614
dplawrence@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Adaptimmune

Study Contact

David Hong, MD
713-563-5844
dshong@madanderson.org

Detailed Description

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.