MAGE-A4ᶜ¹º³²T for Multi-Tumor

Conditions:Lung Cancer, Skin Cancer, Ovarian Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Bladder Cancer
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:May 15, 2017
End Date:September 2035

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Phase 1 Dose Escalation, Multi-tumor Study to Assess the Safety, Tolerability and Antitumor Activity of Genetically Engineered MAGE-A4ᶜ¹º³²T in HLA-A2+ Subjects With MAGE-A4 Positive Tumors

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.

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

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.
We found this trial at
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Brian Van Tine, M.D.
Phone: 314-747-7997
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
Saint Louis, MO
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Kunle Odunsi, MD, PhD
Phone: 716-845-8409
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
Buffalo, NY
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Miami, Florida 33124
(305) 284-2211
Principal Investigator: Brian Slomovitz, MD
Phone: 305-243-7648
University of Miami A private research university with more than 15,000 students from around the...
Miami, FL
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Houston, Texas 77030
Principal Investigator: David Hong, MD
Phone: 713-792-4384
Houston, TX
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Nashville, Tennessee 37203
Principal Investigator: Melissa Johnson, MD
Phone: 615-339-4214
Nashville, TN
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Philadelphia, Pennsylvania 19111
Principal Investigator: Anthony Olszanski, MD, RPh
Phone: 215-728-2195
Philadelphia, PA
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Toronto, Ontario
Principal Investigator: Marcus Butler, MD
Phone: 416-946-4501
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