CAR T-Cell Therapy for Glioblastoma

Phase 1

Waitlist Available

Research Sponsored by Chimeric Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new cancer treatment (CHM-1101) for glioblastoma to see if it is safe & effective.

Who is the study for?

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.

What is being tested?

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).

What are the potential side effects?

While specific side effects aren't listed here, CAR-T cell therapies often include flu-like symptoms, fatigue, fever, difficulty breathing, confusion and may lead to more severe issues like low blood pressure or organ inflammation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to15 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

All other adverse events and toxicities

Cytokine Release Syndrome (CRS)

Dose-limiting toxicity (DLT)

Secondary study objectives

Chimeric antigen receptor (CAR) T cell

Clinical benefit rate

Disease response

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Do I qualify?Apply below to find out