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TGFβR2KO/IL13Rα2 CAR T-Cells for Recurrent Glioblastoma or Astrocytoma

This study is testing a new treatment called TGFβR2KO/IL13Rα2 CAR T-cells for people with glioblastoma or IDH-mutant astrocytoma (a type of brain tumor) that has come back or is getting worse. CAR T-cell therapy uses your own immune cells (T-cells) that are specially modified in the lab to find and attack cancer cells. In this study, these modified T-cells are given directly into the brain. The main goal is to see how safe this treatment is and to find the best dose. Researchers will also look at how well the treatment works and if it helps people live longer. This study is for adults aged 18 and older. The current status of this study is unclear, and it plans to enroll 27 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 27 participants to test the safety and best dose of the treatment.
What's involved
You would undergo procedures like blood and spinal fluid collection, echocardiography (an ultrasound of the heart), and FDG-PET scans. You would also have a catheter placed in your skull to deliver the CAR T-cells.
Compensation
Not stated in the trial record.
Follow-up
The study will monitor for side effects for up to 30 days after your last dose of the study drug. They will also assess how well the treatment works at 3, 6, and 9 months, and overall survival at 9 months.

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

NCT06815029

Intracranial Genetically Modified Immune Cells (TGFβR2KO/IL13Rα2 CAR T-Cells) for the Treatment of Recurrent or Progressive Glioblastoma or Grade 3 or 4 IDH-Mutant Astrocytoma

Recruiting
PHASE1Ages 18+InterventionalTreatment
City of Hope Medical Center
~27 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:Biospecimen CollectionChimeric Antigen Receptor T-Cell TherapyEchocardiographyFludeoxyglucose F-18Intracranial Catheter PlacementLeukapheresis

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose-limiting toxicities (DLTs)
Measured over Up to 28 days
+3 more outcomes measured

Conditions

Recurrent Astrocytoma, IDH-Mutant, Grade 3
Recurrent Astrocytoma, IDH-Mutant, Grade 4
Recurrent Glioblastoma

Explore related trials

AstrocytomaGlioblastomaIDH1 wt AlleleIL13RA2 Gene

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Behnam Badie · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

Behnam Badie
[email protected]
626-218-7293
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Documented informed consent of the participant and/or legally authorized representative
Note: For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter/translator to proceed with screening and leukapheresis, while the request for a translated main consent is processed. However, the research participant is allowed to proceed with surgery/Rickham placement and CAR T cell infusion only after the translated main consent form is signed
Agreement to allow the use of archival tissue from diagnostic tumor biopsies. If unavailable, exceptions may be granted with study principal investigator (PI) approval
Age: ≥ 18 years
Karnofsky performance status (KPS) ≥ 70%, Eastern Cooperative Oncology Group (ECOG) ≤ 2
Life expectancy ≥ 4 weeks
If the participant has a shunt, they must be informed of the following:
If the shunt is not programmable, the participant must be willing to have a programmable shunt placed prior to CAR T cell infusion, and
If the shunt is programmable, in order to proceed to the treatment portion of the study, the participant must be able to tolerate their shunt being functionally closed for at least 2 hours
Participant has a prior histologically-confirmed diagnosis of a grade 3 or 4 IDH-mutant astrocytoma or glioblastoma, or has a prior histologically-confirmed diagnosis of a grade 2 or 3 astrocytoma and now has radiographic progression consistent with grade 3 or 4 IDH-mutant astrocytoma
Relapsed disease: radiographic evidence of recurrence/progression of measurable disease after standard therapy, and ≥ 12 weeks after completion of front-line radiation therapy
COH clinical pathology confirms IL13Rα2+ tumor expression by immunohistochemistry (H-score ≥ 80)
No known contraindications to leukapheresis, steroids, or tocilizumab
White blood cell (WBC) \> 2000 /dl (or absolute neutrophil count \[ANC\] ≥ 1,000/mm\^3) (to be performed within 14 days prior to leukapheresis unless otherwise stated)
Platelets ≥ 75,000/mm\^3 (to be performed within 14 days prior to leukapheresis unless otherwise stated)
Hemoglobin ≥ 8g/dl (to be performed within 14 days prior to leukapheresis unless otherwise stated)
Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (to be performed within 14 days prior to leukapheresis unless otherwise stated)
Aspartate aminotransferase (AST) ≤ 2.5 x ULN (to be performed within 14 days prior to leukapheresis unless otherwise stated)
Alanine aminotransferase (ALT) ≤ 2.5 x ULN (to be performed within 14 days prior to leukapheresis unless otherwise stated)
Serum creatinine ≤ 1.6 mg/dL (to be performed within 14 days prior to leukapheresis unless otherwise stated)
Oxygen (O2) saturation ≥ 95% on room air (to be performed within 14 days prior to leukapheresis unless otherwise stated)
Seronegative for HIV antigen/antibody (Ag/Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative) (to be performed within 14 days prior to leukapheresis unless otherwise stated)
Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test (to be performed within 14 days prior to leukapheresis unless otherwise stated)
If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
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 3 months after the last dose of protocol therapy
Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)

Exclusion

Owing to higher frequency of wound-related complications, participants who require active bevacizumab therapy at the time of enrollment are excluded
Participant has 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 autoimmune disease requiring systemic immunosuppressive therapy
Active infection requiring intravenous (IV) antibiotics (e.g., minor scalp infection is not an exclusion)
Known history of human immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection
Other active malignancy. Note: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Females only: Pregnant or breastfeeding
Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
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

  • Dose-limiting toxicities (DLTs)Up to 28 days

    Will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Rate and associated 90% Clopper and Pearson binomial confidence limits (90% CI) will be estimated for participants experiencing DLTs at the maximum tolerated dose schedule

  • Incidence of grade 3+ adverse events (AEs)Up to 30 days after last dose of study drug

    Will be assessed using the CTCAE v 5.0. Tables will be created to summarize all toxicities and side effects by dose, time post treatment, organ, severity, attributions, and arm. In study participants who received the full schedule of 4 cycles.

  • Incidence of cytokine release syndromeUp to 30 days after last dose of study drug

    Will be graded using American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Criteria. Tables will be created to summarize all toxicities and side effects by dose, time post treatment, organ, severity, attributions, and arm. In study participants who received the full schedule of 4 cycles.

  • Incidence of all other AEsUp to 30 days after last dose of study drug

    Will be assessed using the CTCAE v 5.0. Neurotoxicity will be graded using ASTCT Consensus Criteria, Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome grading system, and tumor inflammation-associated neurotoxicity grading system. Tables will be created to summarize all toxicities and side effects by dose, time post treatment, organ, severity, attributions, and arm.