Safety and Efficacy of Targeted IL-13 Rα2 or B7-H3 UCAR-T for Advanced Glioma
NCT ID: NCT05752877
Last Updated: 2023-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
12 participants
INTERVENTIONAL
2021-05-01
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Interventional Group
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Soochow T-Maximun Biotechnology Co. LTD
UNKNOWN
Second Affiliated Hospital of Soochow University
OTHER
Responsible Party
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Locations
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The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SJWKtumor001
Identifier Type: -
Identifier Source: org_study_id
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