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About
The main goal of this trial is to evaluate the safety and tolerability of CAR T cell therapy for advanced solid tumors with positive mesothelin and MUC1.Patients were screened, peripheral blood mononuclear cells (PBMC) were isolated from eligible patients, and cells were prepared. Pretreatment was performed within 5 days before infusion, and CAR T cells were infused on day 0 (the dose was determined according to the requirements of climbing/expansion). The safety intensive observation period was 28 days after infusion, and the clinical efficacy after infusion was evaluated on days 28-34. The follow-up observation and evaluation were carried out according to the follow-up visit point, and the follow-up period was 1 year. From the second year, the telephone follow-up period was entered.
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Inclusion criteria
Patients diagnosed with advanced solid tumors through histopathological diagnosis have a positive rate of ≥ 50% for mesothelin expression membrane and ≥ 50% for MUC1 expression in tumor tissue samples. PD-L1 expression is positive, and the sample source is within 2 years;
Late stage malignant solid tumor patients who have failed standard treatment or are intolerant to such treatment and do not have a standard effective treatment plan ;
Greater than or equal to 18 years of age and less than or equal to 70 years of age on day of signing informed consent;
Life expectancy >3 months;
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
Satisfactory organ and bone marrow function as defined by the following:
Subjects must have measureable disease as defined by RECIST 1.1 criteria;
Subjects sufficiently understand the trial and willingly sign the informed consent;
Male and Female subjects agree to use approved contraceptive methods (e.g. birth control pills, barrier device, intrauterine device, abstinence) during the study and for at least 12 months following the last dose of the study cell infusion and until no CAR-T cells can be detected after two consecutive PCR tests.
Exclusion criteria
Primary purpose
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Interventional model
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20 participants in 1 patient group
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Central trial contact
Yong Xia
Data sourced from clinicaltrials.gov
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