CAR T Cells in Patients With MMP2+ Recurrent or Progressive Glioblastoma (NCT05627323) | Clinical Trial Compass
Active — Not RecruitingPhase 1
CAR T Cells in Patients With MMP2+ Recurrent or Progressive Glioblastoma
United States42 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 range18 Years
SexALL
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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…