Safety and Efficacy of Targeted IL-13 Rα2 or B7-H3 UCAR-T for Advanced Glioma

Trial Title: Safety and Efficacy of Targeted IL-13 Rα2 or B7-H3 UCAR-T for Advanced Glioma

NCT ID: NCT05752877

Condition: Advanced Glioma
Complication of Chimeric Antigen Receptor (CAR-T) Cell Therapy

Conditions: Official terms:
Glioma

Study type: Interventional

Study phase: N/A

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: Targeted IL-13 Rα2 UCAR-T cell injection
Description: local administration (intracranial cavity or intravertebral injection after surgery): 1 ampoule (about 2-5 ml, 1-5×10^7 cells) for 1-2 minutes each time.
Arm group label: Interventional Group

Intervention type: Biological
Intervention name: Targeted B7-H3 UCAR-T cell injection
Description: local administration (intracranial cavity or intravertebral injection after surgery): 1 ampoule (about 2-5 ml, 1-5×10^7 cells) for 1-2 minutes each time.
Arm group label: Interventional Group

Summary: The goal of this clinical trial is to estimate the safety, tolerance and initial efficacy of target IL-13Rα2 or B7-H3 UCAR-T cell injection in the treatment of patients with advanced glioma, as well as the pharmacokinetic characteristics of its metabolites after single and multiple administrations and the biomarkers related to efficacy, safety and drug metabolism.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 18-70 years old, male or female, and the expected survival period is not less than 3 months. - Advanced, locally advanced or recurrent tumor diagnosed histologically or cytologically. - Failed in previous standard treatment or gived up treatment for various reasons after failure of first-line treatment. - Failed in therapy by PD-1 or PD-L1 antibody or stopped administration of PD-1 or PD-L1 antibody for more than 4 weeks. - At least 1 measurable target lesion (RECIST v1.1). - 0-2 in ECOG physical state score. - Available initial or recurrent tumor tissue for at least 10 stanable and detectable sections. - Blood routine test: WBC ≥ 3×10^9/L, lymphocyte percentage (LY%) ≥ 15%, hemoglobin Hbo (Hb) ≥ 90g/L, platelet (PLT) ≥ 60×10^9/L. - Liver and kidney functions: alanine transaminase (ALT) and aspartate transaminase (AST) < 3 times of the normal value, total bilirubin (TBiL) < 1.5 times of the normal value, serum creatinine (SCR) < 1.5 times of the normal value. - IL-13Rα2 or B7-H3 antigen expression > 50%. - Volunteered to enroll this study and signed the informed consent with good compliance and cooperation with follow-up. - Experienced radiotherapy and chemotherapy with an interval of more than 4 week. Exclusion Criteria: - Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood HBV DNA titer ≥ 5 × 10^2 copies/L; HCV antibody and peripheral blood HCV RNA positive; Human immunodeficiency virus (HIV) antibody positive; CMV DNA test positive; Syphilis test positive. - Experienced any gene therapy previously. - Needing long-term immunosuppressants for any reason. - Any serious and uncontrolled systemic autoimmune disease or any unstable systemic disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease and temporal arteritis. - Severe heart, lung, liver and kidney insufficiency or severe debilitating lung disease; Cardiac function: Grade III or above according to NYHA standard; Liver function: grade C in Child-Puge grading standard; Renal function: chronic kidney disease (CKD) more than stage 4; Renal insufficiency above stage Ⅲ; Lung function: symptoms of severe respiratory failure, involving other organs; Brain function: abnormality of central nervous system or disturbance of consciousness. - Administrating of systematical steroids currently (except usage inhaled steroids recently or currently). - Pregnancy and lactation (the safety of this treatment for unborn children is not clear, and female participants with reproductive potential must have negative serum or urine pregnancy test within 48 hours before administration). - Allergy to immunotherapy and related drugs. - Complicated with another tumor. - History of organ transplantation or waiting for organ transplantation. - After evaluation by researcher,noncompliance with the requirements of the study protocol was confirmed.

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: The Second Affiliated Hospital of Soochow University

Address:
City: Suzhou
Zip: 215004
Country: China

Status: Recruiting

Contact:
Last name: Qing Lan, Doctor

Phone: 051267784087
Email: szlq006@163.com

Start date: May 1, 2021

Completion date: April 30, 2026

Lead sponsor:
Agency: Second Affiliated Hospital of Soochow University
Agency class: Other

Collaborator:
Agency: Soochow T-Maximun Biotechnology Co. LTD
Agency class: Other

Source: Second Affiliated Hospital of Soochow University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05752877