Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant Glioma (NCT02208362) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant Glioma
United States65 participantsStarted 2015-05-18
Plain-language summary
This phase I trial studies the side effects and best dose of genetically modified T-cell immunotherapy in treating patients with malignant glioma that has come back (recurrent) or has not responded to therapy (refractory). A T cell is a type of immune cell that can recognize and kill abnormal cells in the body. T cells are taken from the patient's blood and a modified gene is placed into them in the laboratory and this may help them recognize and kill glioma cells. Genetically modified T-cells may also help the body build an immune response against the tumor cells.
Who can participate
Age range
12 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:
* SCREENING INCLUSION CRITERIA
* Participant has a prior histologically-confirmed diagnosis of a grade III or IV glioma, or has a prior histologically-confirmed diagnosis of a grade II glioma and now has radiographic progression consistent with a grade III or IV malignant glioma (MG) after completing standard therapy
* Radiographic evidence of progression/recurrence of the measurable disease more than 12 weeks after the end of the initial radiation therapy
* Karnofsky performance status (KPS) \>= 60%
* Life expectancy \> 4 weeks
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
* City of Hope (COH) Clinical Pathology confirms IL13R alpha 2+ tumor expression by immunohistochemistry (\>= 20%, 1+)
* All research participants must have the ability to understand and the willingness to sign a written informed consent
* ELIGIBILITY TO PROCEED WITH PERIPHERAL BLOOD MONONUCLEAR CELL (PBMC) COLLECTION
* Research participant must not require more than 2 mg three times daily (TID) of dexamethasone on the day of PBMC collection.
* Research participant must have appropriate venous access
* At least 2 weeks must have elapsed since the research parti…
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.
1Since this is a Phase 1 trial focused on measuring serious side effects and toxic dose limits of CAR T-cell therapy, what does that mean for what's currently known — and not yet known — about whether this treatment might actually help shrink my tumor?
2The trial is actively treating patients but no longer enrolling new ones — does that mean there's any chance of a waitlist or companion study, or should we focus on finding other options right now?
3CAR T-cell therapy involves genetically modifying my own immune cells to attack the tumor — what does that process actually involve in terms of time, hospital stays, and how it might affect my day-to-day life during treatment?
4Given that the trial covers both Grade II and Grade III recurrent gliomas as well as glioblastoma, how would my specific diagnosis and prior treatments affect whether this approach would even make sense to pursue?
5Are there standard treatments or other clinical trials I should consider alongside or before exploring a CAR T-cell study like this one, especially since this is still in the safety-testing phase?
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 Participants With Grade 3 or Higher Toxicity Related to CAR T Cells
Timeframe: An average of 11 months
2
Number of Participants Experiencing a Dose Limiting Toxicity (DLT)
Timeframe: Up to 1 week following the last course, up to a total of 4 weeks (not including optional courses 4-6)