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Experimental CAR t cell cocktail takes on recurrent glioblastoma

NCT ID NCT04003649

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tests whether a special type of immune cell (CAR T cell) that targets a protein found on glioblastoma cells can be safely given along with two immunotherapy drugs (nivolumab and ipilimumab). The study involves 20 adults with recurrent or treatment-resistant glioblastoma. The main goals are to check for side effects and see if the treatment is feasible before and after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IL13Rα2-targeted CAR T cells (a type of immune cell therapy) combined with nivolumab and ipilimumab (immunotherapy drugs)
What this could lead to
If successful, this could point toward a new treatment option for recurrent glioblastoma, a brain cancer with very few effective therapies.
What could go wrong
This is a very early (phase 1) and small trial (20 people), focused mainly on safety. The combination may cause serious side effects or fail to improve outcomes.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

20 people

The number who actually took part.

Started

Dec 2019

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria Informed Consent and Willingness to Participate * 1\. Documented informed consent of the participant and/or legally authorized representative. Assent, when appropriate, will be obtained per institutional guidelines. * 2\. Agreement to allow the use of archival tissue from diagnostic tumor biopsies. If unavailable, exceptions may be granted with Study PI approval. Age Criteria, Performance status * 3\. Ages ≥18 years * 4\. KPS ≥ 60%, ECOG ≤ 2 * 5\. Life expectancy ≥ 4 weeks Nature of Illness and Illness Related Criteria * 6\. Histologically confirmed diagnosis of WHO classification grade IV GBM, or has a prior histologicallyconfirmed diagnosis of a grade II or III glioma and now has radiographic progression consistent with a grade IV GBM after completing standard therapy. * 7\. Relapsed/refractory disease: radiographic evidence of recurrence/progression of measurable disease after standard therapy, and ≥ 12 weeks after completion of front-line radiation therapy. * 8\. COH Clinical Pathology confirms IL13Rα2+ tumor expression by IHC at the initial tumor presentation or recurrent disease (H-score \> 50; reference Appendix B) * 9\. Participants with a known history of congestive heart failure (CHF) or cardiac symptoms consistent with NYHA classification III-IV within 6 months prior to Day 1 of protocol treatment, cardiomyopathy, myocarditis, Myocardial Infarction (MI), exposure to cardiotoxic medications or with clinical history suggestive of the above must have an EKG and Echocardiogram (ECHO) performed within 42 days prior to registration and as clinically indicated while on treatment. Clinical Laboratory and Organ Function Criteria (To be performed within 14 days prior to leukapheresis unless otherwise stated. * 10\. WBC \> 2000 /dl (or ANC ≥ 1,000/mm3) * 11\. Platelets ≥ 75,000/mm3 * 12\. Fasting Blood glucose within ULN * 13\. Total bilirubin ≤ 1.5 ULN * 14\. AST ≤ 2.5x ULN * 15\. ALT ≤ 2.5x ULN * 16\. Serum creatinine ≤1.6 mg/dL * 17\. O2 saturation ≥ 95% on room air * 18\. Seronegative for HIV Ag/Ab combo, Hepatitis C Ab\*, active HBV (Surface Antigen Negative), Hepatitis A Virus IgM Antibody \*If positive, Hepatitis C RNA quantitation must be performed. * 19\. Women of childbearing potential (WOCBP): negative urine or serum pregnancy test If the urine test is positive or cannot be * 20\. Agreement by females and males 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 5 months after the last dose of nivolumab and/or 3 months after the last cycle of CAR T cells. Exclusion Criteria Prior and concomitant therapies * 1\. Prior CTLA-4, PD-1 or PD-L1 inhibitor therapy. * 2\. Participant is steroid-dependent, requiring more than 6 mg of dexamethasone per day at the time of enrollment. * 3\. Participant has not yet recovered from toxicities of prior therapy. Other illnesses or conditions * 4\. History of or active autoimmune disease * 5\. Uncontrolled seizure activity and/or clinically evident progressive encephalopathy * 6\. History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent * 7\. Active diarrhea * 8\. Clinically significant uncontrolled illness * 9\. Active infection requiring antibiotics * 10\. Known history of immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection * 11\. Other active malignancy * 12\. Females only: Pregnant or breastfeeding * 13\. 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. Noncompliance * 14\. Prospective participants 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

  • City of Hope Medical Center

    Duarte, California, 91010, United States

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