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

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05752877
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Second Affiliated Hospital of Soochow University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Advanced Glioma, Complication of Chimeric Antigen Receptor (CAR-T) Cell Therapy

Arms & Interventions

Arms

Experimental: Interventional Group

Interventions

Biological: - Targeted IL-13 Rα2 UCAR-T cell injection

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.

Biological: - Targeted B7-H3 UCAR-T cell injection

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.