MAGE-A10ᶜ⁷⁹⁶T for Urothelial Cancer, Melanoma or Head and Neck Cancers (NCT02989064) | Clinical Trial Compass
CompletedPhase 1
MAGE-A10ᶜ⁷⁹⁶T for Urothelial Cancer, Melanoma or Head and Neck Cancers
United States, Canada, Spain10 participantsStarted 2016-10
Plain-language summary
This Phase 1 study is designed as a cell dose escalation trial in HLA-A\*02:01 and HLA-A\*02:06 subjects with MAGE-A10 positive urothelial, melanoma or head and neck tumors. The study will enroll subjects between the ages of 18 and 75 using a modified 3+3 cell dose escalation design, to evaluate dose limiting toxicities and determine the target cell dose range. Following the dose escalation phase, additional subjects will be enrolled at the target cell dose range to further characterize safety and the effects at this cell dose.
The study will take the subject's T cells, which are a natural type of immune cell in the blood, and send them to a laboratory to be modified. The changed T cells used in this study will be the subject's own T cells that have been genetically changed with the aim of attacking and destroying cancer cells. When the MAGE-A10ᶜ⁷⁹⁶T cells are available, subjects will undergo lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by T cell infusion. The purpose of this study is to test the safety of genetically changed T cells and find out what effects, if any, they have in subjects with urothelial, melanoma or head and neck cancer.
Subjects will be seen frequently by the Study Physician after receiving their T cells for the next 6 months. After that, subjects will be seen every 3, 6, or 12 months according to the Schedule of Procedures. All subjects completing or withdrawing from the interventional portion of the study will enter a long term follow-up phase for observation of delayed adverse events and overall survival for 15 years post-infusion.
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 following cancers: (A) urothelial cancer (transitional cell cancer of the bladder, ureter or renal pelvis), (B) melanoma, or (C) squamous cell carcinoma of the head and neck.
. Subject is HLA-A\*02:01 and/or HLA-A\*02:06 positive.
. 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.
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
Number of subjects with adverse events (AE), including serious adverse events (SAE).
Timeframe: 3 years
2
Evaluation of the persistence of genetically modified T cells
Timeframe: 3 years
3
Measurement of RCL in genetically modified T cells.
Timeframe: 3 years
4
Assessment of dose limiting toxicities to determine optimally tolerated dose range
Timeframe: 3 years
5
Proportion of subjects with a confirmed Complete Response (CR) and/or Partial Response (PR).
Timeframe: 3 years
6
Interval between the date of first T cell infusion dose and first documented evidence of CR or PR.
Timeframe: 3 years
7
Interval between the date of first documented evidence of CR or PR until first documented disease progression or death due to any cause.
. Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
Exclusion criteria
. Subject is HLA-A\*02:05 in either allele, HLA-B\*15:01 and/or HLA-B\*46:01 positive. Subject has any A\*02 null allele (designated with an "N", e.g. A\*02:32N) as the sole HLA-A\*02 allele.
. Subject has received or plans to receive excluded therapy/treatment prior to leukapheresis or lymphodepleting chemotherapy per protocol
. Subject that has toxicity from previous anti-cancer therapy must have recovered to ≤ Grade 1 prior to enrollment
. Subject has history of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study.
. Subject had major surgery within 4 weeks prior to lymphodepletion; subjects should have been fully recovered from any surgical related toxicities.
. Subject has an electrocardiogram (ECG) showing clinically significant abnormality at Screening or showing an average QTc interval ≥450 msec in males and ≥470 msec in females (≥480 msec for subjects with bundle branch block \[BBB\]) over 3 consecutive ECGs. Either Fridericia's or Bazett's formula may be used to correct the QT interval.
. Subject has symptomatic CNS metastases.
. Subject has a history of chronic or recurrent severe autoimmune or immune mediated disease
8
Interval between the date of first documented evidence of SD until first documented disease progression or death due to any cause.
Timeframe: 3 years
9
Interval between the date of first T cell infusion and the earliest date of disease progression or death due to any cause
Timeframe: 3 years
10
Interval between the date of first T cell infusion and date of death due to any cause.
Timeframe: 3 years
11
Number and % of subjects having any Long Term Follow Up Adverse Events (AEs)
Timeframe: 15 years post last treatment (infusion)