CAR T-Cell Therapy for Glioblastoma

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Chimeric Therapeutics

No Placebo Group

Trial Summary

What is the purpose of this trial?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).

Eligibility Criteria

This trial is for adults over 18 with confirmed grade 4 glioblastoma or malignant glioma that's worsened to grade 4, and have MMP2+ tumors. They must be in relatively good health (ECOG status of 0 or 1), not pregnant, agree to birth control, HIV negative, and without significant other illnesses. Those who've had recent bevacizumab therapy or uncontrolled seizures can't join.

Inclusion Criteria

Agreement to allow the use of archival tissue from diagnostic tumor biopsies

Women of childbearing potential must have a negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required

Seronegative for hepatitis B and/or hepatitis C virus

+12 more

Exclusion Criteria

I do not have any other active cancer.

I received bevacizumab therapy within the last 3 months.

I am still experiencing side effects from my previous cancer treatment.

+8 more

Participant Groups

The study tests CHM-1101 CAR-T cells on patients with recurrent or worsening glioblastoma. It aims to find the safest dose and measure how effective these genetically engineered immune cells are at targeting tumor cells expressing a specific protein (MMP2).

2Treatment groups

Experimental Treatment

Group I: Treatment (CAR T cell therapy) 2Experimental Treatment1 Intervention

Arm 2 participants will undergo resection of their tumor. Participants receive half the CHM-1101 dose via Rickham catheters into the tumor cavity and half into the lateral ventricle. Cycle 1 (28 days) CHM 1101 total dose will be divided across 3 once-weekly administrations. After Cycle 1, additional cycles may be initiated in the absence of disease progression or unacceptable toxicity provided that the principal investigator and participant agree to continue and if adequate autologous CAR-T doses remain.

Group II: Treatment (CAR T cell therapy) 1Experimental Treatment1 Intervention

Arm 1 participants will undergo resection of their tumor. Participants receive half the CHM-1101 dose via Rickham catheters into the tumor cavity and half into the lateral ventricle. Cycle 1 (28 days) CHM 1101 total dose will be divided across 3 once-weekly administrations. After Cycle 1, additional cycles may be initiated in the absence of disease progression or unacceptable toxicity provided that the principal investigator and participant agree to continue and if adequate autologous CAR-T doses remain.