CAR T Cells in Patients With MMP2+ Recurrent or Progressive Glioblastoma (NCT05627323) | Clinical Trial Compass
TerminatedPhase 1
CAR T Cells in Patients With MMP2+ Recurrent or Progressive Glioblastoma
Stopped: IND application withdrawn
United States1 participantsStarted 2023-06-06
Plain-language summary
This is a phase 1b study to evaluate the safety of chimeric antigen receptor (CAR) T cells with a chlorotoxin tumor-targeting domain (ie, CHM-1101, the study treatment) to determine the best dose of CHM-1101, and to assess the effectiveness of CHM-1101 in treating MMP2+ glioblastoma that has come back (recurrent) or that is growing, spreading, or getting worse (progressive).
Who can participate
Age range
18 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:
* Documented informed consent of the subject and/or legally authorized representative.
* Agreement to allow the use of archival tissue from diagnostic tumor biopsies.
* Age 18 years and older.
* ECOG status of 0 or 1.
* Life expectancy ≥12 weeks.
* Subject has a prior histologically confirmed diagnosis of a grade 4 glioblastoma multiforme (GBM) or a prior histologically confirmed diagnosis of a grade 2 or 3 malignant glioma and now has radiographic progression consistent with a grade 4 GBM (IDH wild type), grade 4 diffuse astrocytoma (IDH mutant), or has a unifocal relapse of GBM.
* Relapsed disease: radiographic evidence of recurrence/progression of measurable disease after standard therapy and ≥ 12 weeks after completion of front-line radiation therapy.
* Confirmed MMP2+ tumor expression by IHC (≥20% moderate/high MMP2 score \[2+ or 3+\]).
* Adequate venous access to perform leukapheresis.
* No known contraindications to leukapheresis or steroids.
* In-range baseline laboratory values for WBC (\>2000/dL \[or ANC ≥1000/mm\^3\]), platelets (≥75000/mm\^3), total bilirubin (≤1.5xULN), AST (≤2.5xULN), ALT (≤2.5xULN), serum creatinine (≤1.5xmg/dL), and oxygen saturation (≥95% on room air)
* Seronegative for human immunodeficiency virus (HIV) by antigen/antibody (Ag/Ab) testing.
* Seronegative for hepatitis B and/or hepatitis C virus.
* Women of childbearing potential must have a negative urine or serum pregnancy test. If the urine test is positive or cannot b…
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.