MAGE-A4ᶜ¹º³²T for Multi-Tumor (NCT03132922) | Clinical Trial Compass
Active — Not RecruitingPhase 1
MAGE-A4ᶜ¹º³²T for Multi-Tumor
United States, Canada71 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 range
18 Years – 75 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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 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