Engineered immune cells take aim at deadly brain tumors
NCT ID NCT05627323
First seen Jun 26, 2026 · Last updated Jun 30, 2026 · Updated 3 times
Summary
This early-phase trial is testing a new treatment called CHM-1101 for people with a type of brain cancer (glioblastoma) that has come back or is getting worse. The treatment uses the patient's own immune cells, which are modified in a lab to recognize and attack tumor cells. The study will enroll 42 adults to find the safest dose and see if the therapy can shrink tumors or slow the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CHM-1101 CAR T-cells (immune cells engineered to target brain tumor cells)
- What this could lead to
- If successful, this could point toward a new treatment option for recurrent glioblastoma, a brain cancer with few effective therapies.
- What could go wrong
- This is an early Phase 1b trial with only 42 participants, focused mainly on safety and dosing. It may not show strong effectiveness, and CAR T-cell therapy can cause serious side effects like cytokine release syndrome.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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1 person
The number who actually took part.
- Started
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Jun 2023
- Finished
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May 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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.) Exclusion Criteria: * 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. * 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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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City of Hope Medical Center
Duarte, California, 91010, United States
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St. David's South Austin Medical Center - Sarah Cannon - Austin
Austin, Texas, 78704, United States
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Other studies related to the condition(s) this trial covers.
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