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
Criteria:
Inclusion Criteria:
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, adenocarcinoma 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
or protein.
4. Subject has measurable disease according to RECIST v1.1 criteria prior to
lymphodepletion
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.
Exclusion Criteria:
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
HLA-A*02 allele
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.
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Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Facility | Status | Contact |
---|---|---|
University of Miami Miami, Florida 33136 United States |
Recruiting |
Michelle Liendo 305-243-0864 mliendo@med.miami.edu |
Moffitt Cancer Center Tampa, Florida 33612 United States |
Recruiting |
Matt Taddeo 817-745-1346 Matt.Taddeo@moffitt.org) |
Washington University School of Medicine Saint Louis, Missouri 63110 United States |
Recruiting |
Michelle Landeau 314-747-7997 landeaum@wustl.edu |
Roswell Park Cancer Institute Buffalo, New York 14263 United States |
Recruiting |
Amy Whitworth, BSN 716-845-8409 Amy.Whitworth@roswellpark.org |
Duke University Medical Center, Duke Cancer Institute Durham, North Carolina 27710 United States |
Recruiting |
Shawna Savage, RN, BSN 919-668-1462 shawna.savage@duke.edu |
Fox Chase Cancer Center Philadelphia, Pennsylvania 19111 United States |
Recruiting |
Anthony Olszanski, MD, RPh Anthony.Olszanski@FCCC.edu |
Tennessee Oncology - Sarah Cannon Research Institute Nashville, Tennessee 37203 United States |
Recruiting |
Matt Walker 615-339-4214 asksarah@sarahcannon.com |
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 M5G1X6 Canada |
Recruiting |
Adrian Sacher, MD 416-946-4501 TIP@uhn.ca |