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IL13Ra2-CAR T Cells with Immunotherapy for Glioblastoma

This study is looking at new ways to treat glioblastoma, a type of brain cancer that has come back or isn't responding to other treatments. Researchers are testing a treatment called IL13Ralpha2-CAR T cells, which are special immune cells designed to fight cancer. They want to see if these cells work better when given alone or with two other immunotherapy drugs, nivolumab and ipilimumab. These drugs help your body's immune system attack cancer cells. The study aims to understand the side effects and how well these treatments work. It will enroll about 20 adult patients.

Study design
This is a Phase 1 interventional study with a planned enrollment of 20 participants. It will examine the safety and feasibility of different treatment combinations.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for adverse events for up to 15 years after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04003649

IL13Ra2-CAR T Cells With or Without Nivolumab and Ipilimumab in Treating Patients With GBM

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
City of Hope Medical Center
~20 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19-expressing Autologous TN/MEM CellsIpilimumabNivolumabQuality-of-Life AssessmentQuestionnaire Administration

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events
Measured over Up to 15 years
+4 more outcomes measured

Conditions

Recurrent Glioblastoma
Refractory Glioblastoma

Explore related trials

GlioblastomaIL13RA2 Gene

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Behnam Badie, MD · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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

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).

What this trial measures

  • Incidence of adverse eventsUp to 15 years

    Will assess dose limiting toxicity and all toxicities. Toxicity is the primary endpoint and will be assessed using the National Cancer Institute (NCI)'s Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Rates and associated 95% Clopper and Pearson binomial confidence limits (95% confidence interval \[CI\]) will be estimated for participants' experiencing dose limiting toxicity (DLT) during neoadjuvant treatment period (DLT period 1), during adjuvant treatment period (DLT period 2), neo-adjuvant and adjuvant feasibility, as well as survival at 9 months. All toxicities and side effects will be summarized in tables by dose, time period, organ, and severity.

  • Dose-limiting toxicity (DLT)Up to 28 days

    A toxicity that causes side effects that are serious enough to prevent an increase in dose or level of that treatment.

  • Feasibility (neoadjuvant therapy)Up to 14 days

    As measured by the ability of patients receive ipilimumab/nivolumab (\> 80% of the assigned doses) and undergo undergo surgery so that they can go on to receive the first dose of CAR T cells.

  • Feasibility (adjuvant therapy)Up to 28 days

    Defined as the ability of patients to complete 4 cycles of CAR T infusions (\> 80% of the assigned dose) and 2 doses of nivolumab.

  • Overall SurvivalAt 9 months

    The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.