MAGE-A4ᶜ¹º³²T for Multi-Tumor (NCT03132922) | Clinical Trial Compass
Active — Not RecruitingPhase 1
MAGE-A4ᶜ¹º³²T for Multi-Tumor
United States71 participantsStarted 2017-05-15
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subject is ≥18 to 75 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
Exclusion criteria
✕. Subject does not express appropriate HLA-A genotype
✕. Subject is receiving excluded therapy/treatment per protocol
What they're measuring
1
Adverse Events (AE) Including Serious Adverse Events (SAE)
Timeframe: From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years).
2
Peak Persistence
Timeframe: From afamitresgene autoleucel infusion up to 18 months post-infusion
3
Replication Competent Lentivirus (RCL)
Timeframe: From afamitresgene autoleucel infusion to 3 months post-infusion
✕. 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