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Active Not Recruiting
NCT03132922
MAGE-A4ᶜ¹º³²T for Multi-Tumor
Conditions: Urinary Bladder Cancer, Melanoma, Head and Neck Cancer, Ovarian Cancer, Non-Small Cell Lung Cancer, Esophageal Cancer, Gastric Cancer, Synovial Sarcoma, Myxoid Round Cell Liposarcoma, Gastroesophageal Junction
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 71
Sponsor: USWM CT, LLC
Location: University of Miami Miami Florida
Summary
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. This study has a substudy component that will investigate the safety and tolerability of MAGE-A4c1032T cell therapy in combination with low dose radiation in up to 10 subjects.
Eligibility Criteria
Inclusion Criteria:
1. Subject is ≥18 to 75 years of age at the time of signing the study informed consent.
2. Subject has histologically confirmed diagnosis of any one of the indicated tumor types
3. Subject is HLA-A\*02 positive. (This determination will be made under screening protocol ADP-0000-001).
4. Subject's tumor shows expression of the MAGE-A4 RNA or protein. (This determination will be made under screening protocol ADP-0000-001).
5. Adequate organ function as indicated in the study protocol
6. Subject has measurable disease according to RECIST v1.1 criteria prior to lymphodepletion
7. Subject meets disease-specific requirements per protocol
7\. Subject has anticipated life expectancy \> 6 months prior to leukapheresis and \>3 months prior to lymphodepletion.
Exclusion Criteria:
1. Subject does not express appropriate HLA-A genotype
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.
Additional Exclusion Criteria for the Radiation Substudy:
* Subject does not meet eligibility criteria for the main study (ADP-0044-001).
* Subject does not have at least one target lesion amenable to radiation.
* Certain radiation therapy within 6 months of clinical trial are an exclusion.
* Metastatic disease impinging on the spinal cord or threatening spinal cord compression.
Source: ClinicalTrials.gov (NCT03132922). StuddyBuddy aggregates publicly available trial information.
