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

ConditionRecurrent Malignant Glioma
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMing Yang

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Recurrent malignant glioma (WHO grade IV)

Pathologically confirmed and imaging-defined recurrent glioma

ECOG score of 0-2

Age >=18 years

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

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

    Biological/Vaccine

    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.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Single Treatment ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Grade 3 or Higher Treatment-Related Adverse Events

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.

Time frame
From first CAR-T cell infusion through Day 28
2

Progression-Free Survival

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.

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

Secondary outcomes

1

Incidence and Maximum Grade of Cytokine Release Syndrome

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

Time frame
From first CAR-T cell infusion through Day 28
2

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

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

Time frame
From first CAR-T cell infusion through Day 28
3

Overall Survival

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

Time frame
Up to 2 years after first CAR-T cell infusion
4

Objective Response Rate by MRI/PET-CT

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ming Yang

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Sponsor institution

Pecking Union Medical College Hospital, Department of Neurosurgery

Collaborator

Emergency General Hospital, Department of Neurosurgery

Collaborator

Peking University International Hospital

Collaborator

Source ClinicalTrials.gov

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