IL13Rα2 CAR-T for Patients With r/r Glioma

NCT06355908 | Suspended Phase 1

• 1 other identifier: TT002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glioma

Keywords

r/r WHO4 glioma

Outcome Measures

Primary Outcomes (1)

• Safety of IL13Rα2 CAR-T

  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.

  Day 0 - Day 730

Secondary Outcomes (8)

• Overall Response Rate (ORR)

  Day 0 - Day 730

• Duration of Response (DOR)

  Day 0 - Day 730

• Progression Free Survival (PFS)

  Day 0 - Day 730

• Overall Survival (OS)

  Day 0 - Day 730

• Overall Survival (OS) at 6 months (OS6)

  Day 0 - Day 180

Other Outcomes (1)

• The Exploratory Indicators

  Day 0 - Day 730

Study Arms (1)

IL13Rα2 CAR-T

EXPERIMENTAL

Biological: IL13Rα2 CAR-T

Biological: IL13Rα2 CAR-T

Interventions

IL13Rα2 CAR-T BIOLOGICAL

The IL13Rα2 CAR-T cells will be administered via intraventricular infusion every 2 weekly via an Ommaya reservoir.

IL13Rα2 CAR-T

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 18-75 years (including 18 and 75 years old).
• Karnofsky scale score (KPS)≥50.
• Subjects with WHO grade 4 gliomas who have relapsed or progressed during or after standard treatments such as surgery, radiotherapy, and chemotherapy.
• Tumor with IL13Rα2 positive expression.
• Availability in collecting peripheral blood mononuclear cells (PBMCs).
• Adequate laboratory values and adequate organ function.
• Patients with childbearing/fathering potential must agree to use highly effective contraception.

You may not qualify if:

• Pregnant or breastfeeding females.
• Contraindication to bevacizumab.
• Within 5 days prior to the infusion of CAR-T cells, subjects receiving systemic administration of steroids with dosage more than 10mg/d prednisone or the equivalent doses of other steroids (not including inhaled corticosteroid).
• Comorbid with other uncontrolled malignancy.
• Active immunodeficiency virus (HIV) or hepatitis B virus or hepatitis C virus or tuberculosis infection.
• Autoimmune diseases.
• Severe or uncontrolled psychiatric diseases or condition that could increase adverse events or interfere the evaluation of outcomes.
• Subjects who have previously received cell therapy (such as TCR-T, CAR-T, TIL, etc.).
• Subjects with other conditions that would interfere trial participation at the investigator's discretion.

Sponsors & Collaborators

• Yang Zhang: lead
• TCRCure Biopharma Ltd.: collaborator

Study Sites (1)

Beijing Tiantan Hospital

Beijing, China

Location

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

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

Study Officials

• Nan Ji, MD, PhD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

• Yang Zhang

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 23, 2024
• First Posted: April 10, 2024
• Study Start: March 21, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)