Targeted UCAR-T cell therapy for advanced glioma

Clinical Study on Evaluation of Safety and Efficacy of Targeted IL-13 Rα2 or B7-H3 UCAR-T Cell Injection in Treatment of Advanced Glioma

This study is testing a new targeted therapy using special immune cells to see if it can help people with advanced glioma who haven't responded to other treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Second Affiliated Hospital of Soochow University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT05752877 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and initial efficacy of targeted IL-13Rα2 or B7-H3 UCAR-T cell injections in patients with advanced glioma. Participants will receive these targeted therapies to assess their pharmacokinetics and the biomarkers associated with efficacy and safety. The study will include patients who have previously failed standard treatments and will monitor their response to the new therapy. The trial will also analyze the characteristics of the metabolites after single and multiple administrations.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with advanced or recurrent glioma who have failed previous treatments.

Not a fit: Patients with early-stage glioma or those who have not yet undergone standard treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with advanced glioma who have limited alternatives.

How similar studies have performed: Other studies using CAR-T cell therapies have shown promising results, indicating potential success for this novel approach.

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.

Where this trial is running

Suzhou, Jiangsu

• The Second Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Qing Lan, Doctor

Conditions Advanced Glioma; Complication of Chimeric Antigen Receptor Cell Therapy