An Exploratory Study by Fast CAR T Cells

Last updated: March 18, 2024
Sponsor: Shanghai Cell Therapy Group Co.,Ltd
Overall Status: Active - Recruiting

Phase

1

Condition

Neuroblastoma

Treatment

Fast CAR T cells

Clinical Study ID

NCT06327997
BZE2203-A-01
  • Ages 18-70
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients diagnosed with advanced solid tumors through histopathological diagnosis havea positive rate of ≥ 50% for mesothelin expression membrane and ≥ 50% for MUC1expression in tumor tissue samples. PD-L1 expression is positive, and the samplesource is within 2 years;
  • Late stage malignant solid tumor patients who have failed standard treatment or areintolerant 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 onday 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:
  1. absolute neutrophil count must be greater than ≥ 1.5×10^9/L, lymphocyte countmust be greater than ≥ 0.5×10^9/L, platelets must be greater than ≥ 90×10^9/L,hemoglobin must be greater than ≥ 90g/L without transfusion within 7 days ordependency on EPO;
  2. Total bilirubin must be less than or equal to two times (≤2.0x) the institutionalnormal upper limit; transaminases, serum alanine aminotransferase (ALT) oraspartate aminotransferase (AST), must be less than or equal to 2.5 times (≤2.5x)the institutional normal upper limit (≤5x if there is hepatic metastasis);
  3. International normalized ratio (INR) or the PT is not greater than one and onehalf times (≤ 1.5) the upper limit of normal;
  4. Lung function: ≤ CTCAE grade 1 dyspnea and SaO2≥ 91%;
  5. Cardiac function: cardiac ejection fraction (LVEF) must be greater than fiftypercent (≥50%) by echocardiogram or MUGA one month before enrollment.
  • 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. birthcontrol pills, barrier device, intrauterine device, abstinence) during the study andfor at least 12 months following the last dose of the study cell infusion and until noCAR-T cells can be detected after two consecutive PCR tests.

Exclusion

Exclusion Criteria:

  • Subjects who have undergone other anti-tumor treatments (including radiation therapy,chemotherapy, small molecule, biological or immunotherapy, and other study drugs)other than lymphocytes depletion allowed by the protocol within one month prior toCAR-T infusion;
  • Prior therapy with any gene therapy (including CAR-T cell therapy) or any T celltherapy home and abroad;
  • Pregnant or breastfeeding women;
  • Positive serological reactions for HIV and syphilis; Hepatitis B surface antigenpositive, hepatitis B core antibody positive, and hepatitis B virus DNA copy numberhigher than the detection limit and/or greater than or equal to 1000 copies/mL; OrHepatitis C virus infected individuals;
  • Any uncontrollable active infection, coagulation disorders, or any other majorillness;
  • Patients with autoimmune diseases, organ transplantation and other immune relateddiseases under treatment, or long-term use of immunosuppressive drugs such asglucocorticoids: a. Glucocorticoids: users cannot stop using CAR-T cells 72 hoursbefore infusion; b. Immunosuppressants other than glucocorticoids cannot be stopped ≥ 4 weeks before enrollment;
  • History of severe cardiac or pulmonary disease, including hypertension that cannot becontrolled by medication, and any of the conditions occurred within the past 6 months:congestive heart failure (New York Heart Association functional classification ≥3),cardiac angioplasty and stents, myocardial infarction, unstable angina, or otherclinically significant heart disease;
  • Detectable clinically relevant central nervous system (CNS) metastases and/orpathology such as epilepsy/seizure, brain Ischemia/ hemorrhage, dementia, cerebellardisease, or autoimmune disease affecting central nervous system.
  • Patients at high risk of causing bleeding or perforation;
  • Patients who had undergone major surgical procedures or significant trauma within 4weeks before apheresis, or who were expected to require major surgery during the studyperiod;
  • Patient has a known history of a hematologic malignancy, or of another malignantprimary solid tumor concurrently, with the exception of :Patients with in situcervical cancer or breast cancer with no evidence of disease for ≥ 3 years aftercurative treatments;Patients who underwent successful definitive resection of in situcancer with no evidence of disease for ≥5 years;
  • Other circumstances that were deemed by the investigator to be inappropriate for trialparticipation.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Fast CAR T cells
Phase: 1
Study Start date:
March 07, 2024
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Shanghai Mengchao Cancer Hospital

    Shanghai, Shanghai
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.