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 tumor antigen status and whose synovial sarcoma, myxoid/round cell liposarcoma (MRCLS), melanoma, urothelial, head and neck, ovarian, gastric (stomach), esophagogastric junction (EGJ), non-small cell lung (NSCLC), or esophageal cancer that express the MAGE-A4 protein.
Overal Status | Start Date | Phase | Study Type |
---|---|---|---|
Recruiting | July 10, 2019 | Phase 1 | Interventional |
Primary Outcome 1 - Measure: Number of subjects with treatment -related adverse events (AEs), including serious adverse events (SAEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Primary Outcome 1 - Time Frame: 2.5 years
Primary Outcome 2 - Measure: Evaluate safety of ADP-A2M4CD8 through measurement of Replication -competent Retrovirus in genetically engineered T-cells
Primary Outcome 2 - Time Frame: 15 years
Criteria:
- Key Inclusion criteria
- Age ≥18 and ≤ 75 years
- Histologically or cytogenetically confirmed diagnosis of urothelial cancer, melanoma,
ovarian cancer, esophageal , esophagogastric junction (EGJ) cancer, gastric cancer,
non-small cell lung carcinoma (NSCLC), head and neck, synovial sarcoma or myxoid/round
cell liposarcoma (MRCLS)
- Measurable disease according to RECIST v1.1 prior to leukapheresis and
lymphodepletionHLA-A*02 positive.
- 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
Key exclusion criteria
- Positive for HLA-A*02:05 or HLA-A*02 allele other than A*02:07 or A*02 null allele
- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to fludarabine, cyclophosphamide or other agents used in the study
- History of 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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Gender: All
Minimum Age: 18 Years
Maximum Age: 75 Years
Healthy Volunteers: No
Facility | Status | Contact |
---|---|---|
Washington University - School of Medicine Saint Louis, Missouri 63110 United States |
Not yet recruiting |
Nic Perry 314-273-2831 nperry@wustl.edu |
Roswell Park Cancer Institute Buffalo, New York 14040 United States |
Not yet recruiting |
Amy M Whitworth, RN, BSN 716-845-3089 amy.whitworth@roswellpark.org |
Duke University Medical Center, Duke Cancer Institute Durham, North Carolina 27710 United States |
Not yet recruiting |
Shawna Savage, RN, BSN 919-668-1462 shawna.savage@duke.edu |
Fox Chase Cancer Center Philadelphia, Pennsylvania 19111 United States |
Not yet recruiting |
Elisabeth Giraud Elisabeth.Giraud@fccc.edu |
Sarah Cannon Research Institute Nashville, Tennessee 37203 United States |
Not yet recruiting |
Amanda B Mundy, BA 615-329-7400 amanda.mundy@scresearch.net |
M.D. Anderson Cancer Center Houston, Texas 77030 United States |
Recruiting |
Danxia Ke 713-792-4384 dke@mdanderson.org |
Princess Margaret Cancer Centre Toronto, Ontario M5G 2M9 Canada |
Not yet recruiting |
Adrian G Sacher, MD 416-946-4501 TIP@uhn.ca |