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NCT Number: NCT07481721

IL13Rα2 CAR-T Cells Secreting Anti-PD-L1 Antibody for Recurrent Malignant Glioma

This clinical study is designed to evaluate the safety and efficacy of IL13Rα2 CAR-T cells secreting anti-PD-L1 antibody in patients with recurrent malignant glioma. This trial is a multicenter, open-label, non-randomized, single-arm investigator-initiated trial (IIT). Patients who have recurrent malignant glioma will receive IL13Rα2 CAR-T cell therapy and will be monitored for safety, adverse events (AEs), and efficacy outcomes, including overall survival (OS) and progression-free survival (PFS). The study will help assess the potential of this innovative therapy in the treatment of glioma and its ability to control tumor growth by targeting both IL13Rα2 and PD-L1.

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Key information

Conditions

Recurrent Malignant Glioma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

Location contact

Hongliang Mao, Medical Doctor

CONTACT

[email protected]

+86 18756909374

About this study

The primary aim of this study is to evaluate the safety and efficacy of IL13Rα2 CAR-T cells secreting anti-PD-L1 antibody for the treatment of recurrent malignant glioma. Malignant gliomas are aggressive brain tumors with limited treatment options and poor prognosis. Immunotherapy, including CAR-T cells, has shown promise in various cancers, but its application in glioma treatment remains under investigation.

This study will involve patients with recurrent glioma who have failed prior treatments. Participants will receive a single infusion of IL13Rα2 CAR-T cells, which are engineered to recognize and target tumor cells expressing IL13Rα2. The CAR-T cells will be combined with the secretion of anti-PD-L1 antibodies, aimed at overcoming the immune checkpoint inhibition in the tumor microenvironment.

Safety will be assessed by monitoring adverse events (AEs) and cytokine release syndrome (CRS). The efficacy will be evaluated by measuring tumor response, progression-free survival (PFS), and overall survival (OS) over a follow-up period of several months. The study will also assess changes in the immune microenvironment, including immune cell infiltration and expression of immune checkpoint markers.

The trial will be conducted across multiple centers, including major hospitals in China. It aims to provide valuable data on the potential of this dual-target CAR-T therapy in treating gliomas and to assess its feasibility as a clinical treatment option.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Recurrent malignant glioma (WHO grade IV)
  • Pathologically confirmed and imaging-defined recurrent glioma
  • ECOG score of 0-2
  • Age >=18 years
  • Male or female
  • Life expectancy >3 months

Exclusion criteria

  • Severe immune suppression or autoimmune diseases
  • Severe cardiac, liver, kidney, or other major organ dysfunction
  • Pregnant or breastfeeding women
  • Prior treatment with immune checkpoint inhibitors or other immunotherapies
  • Other conditions posing significant risk to the patient or preventing adherence to the study protocol

Treatment and study plan

IL13Rα2 CAR-T Cells Secreting Anti-PD-L1 Antibody

Biological

Autologous IL13Rα2-targeted CAR-T cells engineered to secrete anti-PD-L1 antibody will be administered after lymphodepleting pretreatment. The study includes peripheral intravenous infusion alone or peripheral intravenous infusion combined with intraventricular injection. Peripheral dose-escalation levels are 1×10^6 cells/kg, 3×10^6 cells/kg, and 1×10^7 cells/kg. In the combined administration strategy, the intraventricular dose is 20%-30% of the peripheral dose, with adjustment based on patient tolerability. Patients will be monitored in the ICU or a dedicated inpatient setting during infusion and for adverse events including CRS and ICANS after infusion.

Primary outcomes

  1. Incidence of Grade 3 or Higher Treatment-Related Adverse Events

    Time frame: From first CAR-T cell infusion through Day 28

    Incidence of Grade 3 or higher treatment-related adverse events after infusion of IL13Rα2 CAR-T cells secreting anti-PD-L1 antibody, including serious adverse events. Adverse event severity will be graded according to CTCAE version 5.0.

  2. Progression-Free Survival

    Time frame: Up to 2 years after first CAR-T cell infusion

    Progression-free survival, defined as the time from first CAR-T cell infusion to documented disease progression or death from any cause, whichever occurs first.

Secondary outcomes

  1. Incidence and Maximum Grade of Cytokine Release Syndrome

    Time frame: From first CAR-T cell infusion through Day 28

    Incidence and maximum grade of cytokine release syndrome following CAR-T cell infusion, graded according to ASTCT consensus criteria.

  2. Incidence and Maximum Grade of Immune Effector Cell-Associated Neurotoxicity Syndrome

    Time frame: From first CAR-T cell infusion through Day 28

    Incidence and maximum grade of immune effector cell-associated neurotoxicity syndrome following CAR-T cell infusion, graded according to ASTCT consensus criteria.

  3. Overall Survival

    Time frame: Up to 2 years after first CAR-T cell infusion

    Overall survival, defined as the time from first CAR-T cell infusion to death from any cause.

  4. Objective Response Rate by MRI/PET-CT

    Time frame: Assessed at Day 56, Day 84, and every 3 months thereafter up to 2 years

    Objective response rate, defined as the proportion of participants achieving complete response or partial response based on imaging assessment using multimodal MRI and/or PET-CT.

  5. Change in Tumor Volume on Imaging

    Time frame: Baseline, Day 7, Day 28, Day 56, Day 84, and every 3 months thereafter up to 2 years

    Change in tumor volume from baseline measured by multimodal MRI and/or PET-CT.

  6. Change in Quality of Life Score Measured by EORTC QLQ-C30

    Time frame: Baseline, Day 28, Day 56, Day 84, and every 3 months thereafter up to 2 years

    Change from baseline in quality of life as assessed by the EORTC QLQ-C30 questionnaire.

  7. Change in Karnofsky Performance Status Score

    Time frame: Baseline, Day 28, Day 56, Day 84, and every 3 months thereafter up to 2 years

    Change from baseline in Karnofsky Performance Status score.

  8. Change in Modified Rankin Scale Score

    Time frame: Baseline, Day 28, Day 56, Day 84, and every 3 months thereafter up to 2 years

    Change from baseline in modified Rankin Scale score.

  9. Persistence of CAR-T Cells in Peripheral Blood

    Time frame: Baseline and multiple post-infusion time points through 2 years

    Persistence of IL13Rα2 CAR-T cells in peripheral blood measured by flow cytometry and/or real-time PCR.

  10. Persistence of CAR-T Cells in Cerebrospinal Fluid

    Time frame: Post-infusion time points through 2 years

    Persistence of IL13Rα2 CAR-T cells in cerebrospinal fluid, when available, is measured by flow cytometry and/or real-time PCR.

Study contacts

Contact information is provided by the study sponsor or research team.

Ming Yang, Medical Doctor

CONTACT

[email protected]

+86 138 1065 5237

Sponsors and collaborators

Lead sponsor

Ming Yang

Other

Collaborators

  • Emergency General Hospital, Department of Neurosurgery
  • Pecking Union Medical College Hospital, Department of Neurosurgery
  • Peking University International Hospital

Registry information

Official study title

A Multicenter, Open-Label, Non-Randomized, Single-Arm Investigator-Initiated Trial to Evaluate the Safety and Efficacy of IL13Rα2 CAR-T Cells Secreting Anti-PD-L1 Antibody in Patients With Recurrent Malignant Glioma

Acronym: APIC-RG

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 19, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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