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Trial Title:
IL13Rα2 CAR-T for Patients With r/r Glioma
NCT ID:
NCT06355908
Condition:
Glioma
Conditions: Official terms:
Glioma
Conditions: Keywords:
r/r WHO4 glioma
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
IL13Rα2 CAR-T
Description:
The IL13Rα2 CAR-T cells will be administered via intraventricular infusion every 2 weekly
via an Ommaya reservoir.
Arm group label:
IL13Rα2 CAR-T
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.
Criteria for eligibility:
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.
Gender:
All
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Tiantan Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Yang Zhang, MD, phD
Phone:
+861059976516
Email:
zhangyang8025@yeah.net
Start date:
March 21, 2024
Completion date:
May 1, 2027
Lead sponsor:
Agency:
Yang Zhang
Agency class:
Other
Collaborator:
Agency:
TCRCure Biopharma Ltd.
Agency class:
Industry
Source:
Beijing Tiantan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06355908
