IL13Rα2 CAR-T treatment for recurrent glioma
Safety, Tolerability and Efficacy of Enhanced IL-13Rα2 Targeted Chimeric Antigen Receptor T Cell Immunotherapy Against Recurrent/Refractory Grade 4 Glioma
This study is testing a new CAR-T cell therapy for patients with recurrent gliomas to see if it is safe and effective for those whose tumors have not responded to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Drugs / interventions | bevacizumab, CAR-T, chemotherapy, prednisone, Chimeric antigen receptor |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06355908 on ClinicalTrials.gov |
What this trial studies
This clinical trial explores the safety and feasibility of a new CAR-T cell therapy targeting the IL13Ra2 receptor in patients with recurrent or refractory WHO grade 4 gliomas. The study aims to evaluate the maximum tolerable dose and preliminary efficacy of this treatment in a single-arm, open-label design. It will enroll 12-30 patients who have shown progression after standard treatments, focusing on those with IL13Ra2-positive tumors. The trial will also assess pharmacokinetic characteristics to better understand the therapy's behavior in the body.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with IL13Ra2-positive recurrent or refractory WHO grade 4 gliomas.
Not a fit: Patients who are pregnant, breastfeeding, or have uncontrolled malignancies or active viral infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel therapeutic option for patients with a poor prognosis due to recurrent gliomas.
How similar studies have performed: Other studies have shown promise with CAR-T therapies targeting similar receptors in various malignancies, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing
- Beijing Tiantan Hospital — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Nan Ji, MD, PhD — Beijing Tiantan Hospital
- Study coordinator: Yang Zhang, MD, PhD
- Email: zhangyang8025@yeah.net
- Phone: +861059976516
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.