Glioblastoma Multiforme of BrainPhase 1NCT05627323
CAR T Cells in Patients With MMP2+ Recurrent or Progressive Glioblastoma
A Phase 1 study testing CHM-1101 CAR-T cells in people with Glioblastoma Multiforme of Brain, run by Chimeric Therapeutics at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme of Brain
- What is being tested?
- CHM-1101 CAR-T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Jun 2023to 29 May 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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 be confirmed as negative, a serum pregnancy test is required.
- Agreement by women AND men of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of CHM-1101. (Childbearing potential is defined as not being surgically sterilized (women and men) or, for women, having not been free from menses for > 1 year.)
Who cannot join
- Within 3 months of having received prior bevacizumab therapy at the time of enrollment.
- Not yet recovered from toxicities of prior therapy.
- Uncontrolled seizure activity and/or clinically evident progressive encephalopathy.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent.
- Clinically significant uncontrolled illness.
- Active infection requiring antibiotics.
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- Known history of HIV or hepatitis B or hepatitis C infection.
- Other active malignancy.
- Women only-pregnant or breastfeeding.
- Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures.
- Prospective subjects who, in the opinion of the Investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
St. David's South Austin Medical Center - Sarah Cannon - Austin
Austin, Texas, 78704
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: A Phase 1b Study to Evaluate CHM-1101, a CAR T-Cell Therapy With a Chlorotoxin Tumor-Targeting Domain for Patients With Matrix Metallopeptidase 2 Positive (MMP2+) Recurrent or Progressive Glioblastoma Multiforme
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).
Read the detailed description
This is a phase 1b, multicenter, feasibility/safety study of the dual delivery (administered through both intracavitary/intratumoral [ICT] and intraventricular [ICV] catheters) of CHM-1101, an autologous chlorotoxin-chimeric antigen receptor (CLTX-CAR) cell product, in participants with recurrent or progressive GBM. The investigational product is identified as CHM-1101 (CLTX(EQ)28ζ/CD19t+ CAR T cells).
PRIMARY OBJECTIVE
- To determine the recommended phase 2 dose (RP2D) for dual ICT and ICV delivery of CHM-1101 in participants with MMP2+ recurrent or progressive GBM.
SECONDARY OBJECTIVES
- To assess the feasibility and safety of dual delivery of CHM-1101.
- To describe the persistence, expansion, immunogenicity, and phenotype of CHM-1101 and endogenous cells tumor cyst fluid (TCF), peripheral blood (PB), and cerebrospinal fluid (CSF).
- In participants who receive at least 2 of the 3 planned doses of CHM-1101 in Cycle 1:
- Estimate the progression-free survival (PFS) rates
- Estimate the overall survival (OS) rates
- To evaluate the disease response rate.
- Conditions
- Glioblastoma Multiforme of Brain
- Being tested
- CHM-1101 CAR-T cells
- Keywords
- Progressive or recurrent glioblastoma, MMP2+
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHM-1101 CAR-T cellsBiological
Also called Chlorotoxin (EQ)-CD28-CD3zeta-CD19t-expressing CAR T-lymphocytes (via ICT/ICV dual delivery), Chlorotoxin-CD28-CD3z-CD19t-expressing CAR T-cells
Administered via ICT/ICV dual delivery
| Study group | Role | What they receive |
|---|---|---|
| Treatment (CAR T cell therapy) 1 | Experimental | 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. Receives: Biological: CHM-1101 CAR-T cells |
| Treatment (CAR T cell therapy) 2 | Experimental | 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. Receives: Biological: CHM-1101 CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Measured: 28 days
Cytokine Release Syndrome (CRS)
Assessed per American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading guideline, evaluating levels and phenotype detected in tumor cyst fluid (TCF), peripheral blood (PB), and cerebrospinal fluid (CSF) (absolute number per µL by flowcytometry).
Measured: up tp 15 years
All other adverse events and toxicities
Assessed per NCI CTCAE v5.0.
Measured: up to 15 years
Secondary outcomes (7)
Chimeric antigen receptor (CAR) T cell
Assess levels and phenotype detected in tumor cyst fluid (TCF), peripheral blood (PB), and cerebrospinal fluid (CSF) (absolute number per µL by flowcytometry).
Measured: up to 15 years
Endogenous T cell
Assess level and phenotype detected in TCF, PB, and CSF (absolute number per µL by flowcytometry).
Measured: up to15 years
Human anti-CAR antibody (HACA)
Serum samples will be evaluated for HACA against the CLTX(EQ)28ζ therapeutic agent.
Measured: up to 15 years
Progression free survival (PFS) time
Measured from the date of first infusion of CAR-T cells until the first date when progressive disease (PD) is objectively documented or death from any cause, whichever is earlier.
Measured: 12 months
Overall survival (OS)
Measured from the date of first infusion of CAR-T cells until death.
Measured: up to 15 years
Disease response
Assessed by modified Response Assessment in Neuro-Oncology Criteria (RANO) criteria.
Measured: 12 months
Clinical benefit rate
The proportion of participants who experience a complete response, a partial response, or stable disease that is 3 months or greater in duration.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2022
- Study start6 Jun 2023
- Primary completion30 Apr 2026
- Study completion29 May 2026
Why it stopped: IND application withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma Multiforme of BrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two dose levels investigated, with both dose levels proceeding in parallel. Expansion or de-escalation decision rules are based on a traditional 3+3 clinical study design.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chimeric Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05627323
- Sponsor's protocol ID
- CHM-1101-001
- Status last verified
- Jun 2026
- First submitted
- 16 Nov 2022
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study to Evaluate CHM-1101, a CAR T-Cell Therapy With a Chlorotoxin Tumor-Targeting Domain for Patients With Matrix Metallopeptidase 2 Positive (MMP2+) Recurrent or Progressive Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT05627323
- Acronym / sponsor ID
- CHM-1101-001
- Conditions
- Glioblastoma Multiforme of Brain
- Keywords
- Progressive or recurrent glioblastoma, MMP2+
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IND application withdrawn
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Chimeric TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 29 May 2026 (actual)
- First posted
- 25 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This is a phase 1b, multicenter, feasibility/safety study of the dual delivery (administered through both intracavitary/intratumoral [ICT] and intraventricular [ICV] catheters) of CHM-1101, an autologous chlorotoxin-chimeric antigen receptor (CLTX-CAR) cell product, in participants with recurrent or progressive GBM. The investigational product is identified as CHM-1101 (CLTX(EQ)28ζ/CD19t+ CAR T cells).
PRIMARY OBJECTIVE
- To determine the recommended phase 2 dose (RP2D) for dual ICT and ICV delivery of CHM-1101 in participants with MMP2+ recurrent or progressive GBM.
SECONDARY OBJECTIVES
- To assess the feasibility and safety of dual delivery of CHM-1101.
- To describe the persistence, expansion, immunogenicity, and phenotype of CHM-1101 and endogenous cells tumor cyst fluid (TCF), peripheral blood (PB), and cerebrospinal fluid (CSF).
- In participants who receive at least 2 of the 3 planned doses of CHM-1101 in Cycle 1:
- Estimate the progression-free survival (PFS) rates
- Estimate the overall survival (OS) rates
- To evaluate the disease response rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two dose levels investigated, with both dose levels proceeding in parallel. Expansion or de-escalation decision rules are based on a traditional 3+3 clinical study design.
| Arm | Type | Receives |
|---|---|---|
| Treatment (CAR T cell therapy) 1 | Experimental | Biological: CHM-1101 CAR-T cellsArm 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. |
| Treatment (CAR T cell therapy) 2 | Experimental | Biological: CHM-1101 CAR-T cellsArm 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (11 listed)
- Within 3 months of having received prior bevacizumab therapy at the time of enrollment.
- Not yet recovered from toxicities of prior therapy.
- Uncontrolled seizure activity and/or clinically evident progressive encephalopathy.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent.
- Clinically significant uncontrolled illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHM-1101 CAR-T cellsAlso: Chlorotoxin (EQ)-CD28-CD3zeta-CD19t-expressing CAR T-lymphocytes (via ICT/ICV dual delivery), Chlorotoxin-CD28-CD3z-CD19t-expressing CAR T-cellsAdministered via ICT/ICV dual delivery | Biological | Treatment (CAR T cell therapy) 1, Treatment (CAR T cell therapy) 2 |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: 28 days
Assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Cytokine Release Syndrome (CRS)
Time frame: up tp 15 years
Assessed per American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading guideline, evaluating levels and phenotype detected in tumor cyst fluid (TCF), peripheral blood (PB), and cerebrospinal fluid (CSF) (absolute number per µL by flowcytometry).
All other adverse events and toxicities
Time frame: up to 15 years
Assessed per NCI CTCAE v5.0.
7 secondary outcomes
Chimeric antigen receptor (CAR) T cell
Time frame: up to 15 years
Endogenous T cell
Time frame: up to15 years
Human anti-CAR antibody (HACA)
Time frame: up to 15 years
Progression free survival (PFS) time
Time frame: 12 months
Overall survival (OS)
Time frame: up to 15 years
Disease response
Time frame: 12 months
Clinical benefit rate
Time frame: 12 months
Results and safety
The study was stopped early (reason given: IND application withdrawn). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CHM-1101 CAR-T cells in people with Glioblastoma Multiforme of Brain, run by Chimeric Therapeutics at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: IND application withdrawn). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.