This study will investigate the safety and tolerability of MAGE-A4ᶜ¹º³²T cell therapy in subjects who have the appropriate HLA-A2 tissue marker and whose urinary bladder, melanoma, head and neck, ovarian, non-small cell lung, esophageal, gastric, synovial sarcoma, or myxoid/round call liposarcoma (MRCLS) tumor has the MAGE-A4 protein expressed. This study will take a subject's T cells and give them a T cell receptor protein that recognizes and attacks the tumors.
|Overal Status||Start Date||Phase||Study Type|
|Recruiting||May 15, 2017||Phase 1||Interventional|
Primary Outcome 1 - Measure: Number of subjects with adverse events (AE), including serious adverse events (SAEs).
Primary Outcome 1 - Time Frame: 3.5 years
Primary Outcome 2 - Measure: Determining dose limiting toxicities (DLT) and optimally tolerated dose range
Primary Outcome 2 - Time Frame: 3.5 years
Primary Outcome 3 - Measure: Evaluation of persistence of genetically modified T cells.
Primary Outcome 3 - Time Frame: 3.5 years
Primary Outcome 4 - Measure: Measurement of RCL in genetically modified T cells.
Primary Outcome 4 - Time Frame: 3.5 years
1. Subject is ≥18 years of age at the time of signing the study informed consent.
2. Subject has histologically confirmed diagnosis of any one of the following cancers:
urothelial cancer (transitional cell cancer of the bladder, ureter, urethra or renal
pelvis), melanoma, squamous cell carcinoma of the head and neck, ovarian cancer, NSCLC
(squamous, adenosquamous, or large cell), esophageal (squamous and adenocarcinoma) or
gastric cancer, synovial sarcoma or MRCLS.
3. Subject is HLA-A*02 positive and subject's tumor shows expression of the MAGE-A4 RNA
4. Subject has measurable disease according to RECIST v1.1 criteria prior to
5. Subject meets disease-specific requirements per protocol
6. Subject has anticipated life expectancy > 6 months prior to leukapheresis and >3
months prior to lymphodepletion.
1. Subject is HLA-A*02:05 positive in either allele; Subject has HLA-A*02:07 as the sole
HLA-A*02 allele (e.g., a subject with HLA alleles A*02:04 and A*02:07 is eligible); or
Subject has any A*02 null allele (designated with an N", e.g., A*02:32N) as the sole
2. Subject is receiving excluded therapy/treatment per protocol
3. Subject has symptomatic CNS metastases.
4. Subject has any other active malignancy besides the tumor under study within 3 years
prior to Screening. Subject has uncontrolled intercurrent illness.
5. Subject has active infection with HIV, HBV, HCV or HTLV
6. Subject is pregnant or breastfeeding.
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
|University of Miami
Miami, Florida 33136
Michelle Liendo, MSHI
|Washington University School of Medicine
Saint Louis, Missouri 63110
|Roswell Park Cancer Institute
Buffalo, New York 14263
Amy Whitworth, BSN
|Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
|Tennessee Oncology - Sarah Cannon Research Institute
Nashville, Tennessee 37203
|M.D. Anderson Cancer Center
Houston, Texas 77030
|Princess Margaret Cancer Centre
Toronto, Ontario M5G1X6
Marcus Butler, MD