MAGE-A4ᶜ¹º³²T for Multi-Tumor
Trial Status: Active
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.
- Subject is ≥18 years of age at the time of signing the study informed consent.
- Subject has histologically confirmed diagnosis of any one of the indicated tumor types
- Subject is HLA-A*02 positive. (This determination will be made under screening protocol ADP-0000-001).
- Subject's tumor shows expression of the MAGE-A4 RNA or protein. (This determination will be made under screening protocol ADP-0000-001).
- Adequate organ function as indicated in the study protocol
- Subject has measurable disease according to RECIST v1.1 criteria prior to lymphodepletion
- Subject meets disease-specific requirements per protocol
- Subject has anticipated life expectancy > 6 months prior to leukapheresis and >3 months prior to lymphodepletion.
- Subject does not express appropriate HLA-A genotype
- Subject is receiving excluded therapy/treatment per protocol
- Subject has symptomatic CNS metastases.
- Subject has any other active malignancy besides the tumor under study within 3 years prior to Screening. Subject has uncontrolled intercurrent illness.
- Subject has active infection with HIV, HBV, HCV or HTLV
- 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.
University of Miami Miller School of Medicine-Sylvester Cancer Center
Moffitt Cancer Center
Siteman Cancer Center at Washington University
Roswell Park Cancer Institute
Duke University Medical Center
Ohio State University Comprehensive Cancer Center
Fox Chase Cancer Center
M D Anderson Cancer Center
Contact: Danxia Ke
Trial Phase Phase I
Trial Type Treatment
- Primary ID ADP-0044-001
- Secondary IDs NCI-2017-01505
- Clinicaltrials.gov ID NCT03132922