IL13Rα2 CAR-T for Patients With r/r Glioma

Phase 1

Recruiting

• Conditions: Glioma
• Interventions: Biological: IL13Rα2 CAR-T

• Registration Number: NCT06355908
• Lead Sponsor: Yang Zhang

Brief Summary

This is a dose exploration clinical trial to assess the safety and feasibility of the IL13Ra2-targeted CAR-T in glioma.

Detailed Description

Interleukin 13 receptor subunit alpha-2 (IL13Ra2A) is a high-affinity membrane receptor of the anti-inflammatory Th2 cytokine IL13, which is overexpressed in glioma and correlated with poor prognosis.

Chimeric antigen receptor (CAR) T cell therapy is a promising treatment approach for many malignancies. IL13Ra2-targeted CAR-T cells are under investigation in several clinical trials in primary CNS malignancies.

The investigators now designed a new structure CAR targeted IL13Ra2, and initiated a single arm, open, dose exploration clinical trial to evaluate the safety, tolerability, clinical efficacy, and pharmacokinetic characteristics of IL13Rα2 CAR-T for patients with glioma. This clinical trial will enroll 12-30 cases of patients with IL13α2-positive recurrent or refractory WHO grade 4 glioma (r/r WHO4 glioma), aiming to find the maximum tolerable dose (MTD), the recommended phase 2 dose (RP2D) and preliminary efficacy of the new structure IL13Ra2 CAR-T.

Study Timeline

• Study Start: 2024-03-21
• Study First Submitted: 2024-03-23
• Study First Submitted QC: 2024-04-03
• Study First Posted: 2024-04-10
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-19
• Last Update Posted: 2024-06-21
• Primary Completion: 2026-05-01
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IL13Rα2 CAR-T	IL13Rα2 CAR-T	Biological: IL13Rα2 CAR-T

Primary Outcome Measures

Name	Time	Method
Safety of IL13Rα2 CAR-T	Day 0 - Day 730	The safety of IL13Rα2 CAR-T will be assessed based on the totality of dose-limiting toxicity (DLT) and adverse event (AE) data collected during this phase.

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	Day 0 - Day 730	To evaluate the time from the date of the first CAR-T infusion until disease progression per iRANO or death due to any cause.
The levels of cytokines in the CSF and peripheral blood	Day 0 - Day 730	To detect levels of cytokines in the CSF and peripheral blood, cytokines will include IL-2, IL-6, IFN-γ, TNF-α, etc.
Duration of Response (DOR)	Day 0 - Day 730	To evaluate the duration from the time that criteria are met for CR or PR per iRANO until disease progression or death due to any cause.
Overall Survival (OS)	Day 0 - Day 730	To evaluate the time from the date of the first CAR-T infusion to death due to any cause.
Overall Response Rate (ORR)	Day 0 - Day 730	To evaluate the percentage of subjects who have a confirmed partial response (PR) and complete response (CR) per immunotherapy response assessment in neuro-oncology (iRANO) criteria.
The levels of IL13Rα2 CAR-T cell and IL13Rα2 CAR in the CSF and peripheral blood	Day 0 - Day 730	To detect the levels of IL13Rα2 CAR-T cell and IL13Rα2 CAR in the CSF and peripheral blood.
Overall Survival (OS) at 12 months (OS12)	Day 0 - Day 365	To evaluate the percentage of survival subjects at 12 months after the first CAR-T infusion.
Overall Survival (OS) at 6 months (OS6)	Day 0 - Day 180	To evaluate the percentage of survival subjects at 6 months after the first CAR-T infusion.

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, China