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CAR T-cell Therapy
CAR T-Cell Therapy for Glioblastoma
Phase 1
Recruiting
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
Study 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.Check my eligibility
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).See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
All other adverse events and toxicities
Cytokine Release Syndrome (CRS)
Dose-limiting toxicity (DLT)
Secondary outcome measures
Chimeric antigen receptor (CAR) T cell
Clinical benefit rate
Disease response
+4 moreTrial 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.
Find a Location
Who is running the clinical trial?
Chimeric TherapeuticsLead Sponsor
1 Previous Clinical Trials
135 Total Patients Enrolled
Jason Litten, MDStudy DirectorChimeric Therapeutics
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I am currently taking antibiotics for an infection.I am not pregnant or breastfeeding.I am 18 years old or older.I have no health issues that prevent me from undergoing leukapheresis or taking steroids.I have a serious illness that is not under control.My tumor shows high MMP2 levels.I can undergo leukapheresis with my current vein condition.My cancer has returned and grown after treatment and 3 months post-radiation.I am fully active or can carry out light work.I was diagnosed with a high-grade brain tumor that has worsened or recurred.I agree to use birth control or abstain from sex during and for 3 months after the study.I have seizures or worsening brain function that isn't under control.I have a history of HIV or hepatitis B/C.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (CAR T cell therapy) 1
- Group 2: Treatment (CAR T cell therapy) 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this clinical experiment have open enrollment at present?
"Data hosted on clinicaltrials.gov makes clear that this medical trial is not currently in the process of recruiting patients, having last been updated on December 19th 2022. However, there are 446 other studies actively seeking participants at present."
Answered by AI
What adverse effects have been associated with utilizing Treatment 1 (CAR T cell therapy)?
"CAR T cell therapy is still in its early stages, meaning there is minimal information on efficacy and safety. This provides it a score of 1 according to our team at Power's metrics."
Answered by AI
What is the primary intent of this clinical trial?
"According to Chimeric Therapeutics, the lead trial sponsor, Cytokine Release Syndrome (CRS) will be monitored over a 28 day time frame and serve as the primary outcome. Secondary outcomes that are being evaluated include Endogenous T cell number/phenotype in TCF, PB, & CSF; Human anti-CAR antibody levels against CLTX(EQ)28ζ; and Progression free survival (PFS)."
Answered by AI
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