Clinical trial · Interventional
IL13Rα2 CAR-T for Patients With r/r Glioma
Safety, Tolerability and Efficacy of Enhanced IL-13Rα2 Targeted Chimeric Antigen Receptor T Cell Immunotherapy Against Recurrent/Refractory Grade 4 Glioma
NCT06355908CI-TRIAL-00101140ENHANCINGsuspendedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Temporarily suspended for HGRAC filing requirements
Summary
Brief summary (as posted)
This is a dose exploration clinical trial to assess the safety and feasibility of the IL13Ra2-targeted CAR-T in glioma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IL13Rα2 CAR-T | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IL13Rα2 CAR-T
- description
- Biological: IL13Rα2 CAR-T
- interventionNames
- Biological: IL13Rα2 CAR-T
Primary outcomes (1)
- measure
- Safety of IL13Rα2 CAR-T
- timeFrame
- Day 0 - Day 730
- description
- 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 outcomes (8)
- measure
- Overall Response Rate (ORR)
- timeFrame
- Day 0 - Day 730
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion criteria: 1. Male or female aged 18-75 years (including 18 and 75 years old). 2. Karnofsky scale score (KPS)≥50. 3. Subjects with WHO grade 4 gliomas who have relapsed or progressed during or after standard treatments such as surgery, radiotherapy, and chemotherapy. 4. Tumor with IL13Rα2 positive expression. 5. Availability in collecting peripheral blood mononuclear cells (PBMCs). 6. Adequate laboratory values and adequate organ function. 7. Patients with childbearing/fathering potential must agree to use highly effective contraception. Exclusion criteria: 1. Pregnant or breastfeeding females. 2. Contraindication to bevacizumab. 3. 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). 4. Comorbid with other uncontrolled malignancy. 5. Active immunodeficiency virus (HIV) or hepatitis B virus or hepatitis C virus or tuberculosis infection. 6. Autoimmune diseases. 7. Severe or uncontrolled psychiatric diseases or condition that could increase adverse events or interfere the evaluation of outcomes. 8. Subjects who have previously received cell therapy (such as TCR-T, CAR-T, TIL, etc.). 9. Subjects with other conditions that would interfere trial participation at the investigator's discretion.
References
Publications (0)
Data not yet available
No reference posted for this study.