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Trial Title:
An Exploratory Study by Fast CAR T Cells
NCT ID:
NCT06327997
Condition:
Solid Tumor
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Fast CAR T cells
Description:
This study designed three dose groups, each with a dosage of 5.0 ×
10^5/kg、1.0×10^6/kg、5.0×10^6/kg
Arm group label:
Fast CAR T cells
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.
Criteria for eligibility:
Criteria:
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:
1. absolute neutrophil count must be greater than ≥ 1.5×10^9/L, lymphocyte count
must 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 or
dependency on EPO;
2. Total bilirubin must be less than or equal to two times (≤2.0x) the
institutional normal upper limit; transaminases, serum alanine aminotransferase
(ALT) or aspartate 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 one
half 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 fifty
percent (≥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. 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:
- 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 to CAR-T infusion;
- Prior therapy with any gene therapy (including CAR-T cell therapy) or any T cell
therapy home and abroad;
- Pregnant or breastfeeding women;
- Positive serological reactions for HIV and syphilis; Hepatitis B surface antigen
positive, hepatitis B core antibody positive, and hepatitis B virus DNA copy number
higher than the detection limit and/or greater than or equal to 1000 copies/mL; Or
Hepatitis C virus infected individuals;
- Any uncontrollable active infection, coagulation disorders, or any other major
illness;
- Patients with autoimmune diseases, organ transplantation and other immune related
diseases under treatment, or long-term use of immunosuppressive drugs such as
glucocorticoids: a. Glucocorticoids: users cannot stop using CAR-T cells 72 hours
before infusion; b. Immunosuppressants other than glucocorticoids cannot be stopped
≥ 4 weeks before enrollment;
- History of severe cardiac or pulmonary disease, including hypertension that cannot
be controlled 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 other clinically significant heart disease;
- Detectable clinically relevant central nervous system (CNS) metastases and/or
pathology such as epilepsy/seizure, brain Ischemia/ hemorrhage, dementia, cerebellar
disease, 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 4
weeks before apheresis, or who were expected to require major surgery during the
study period;
- Patient has a known history of a hematologic malignancy, or of another malignant
primary solid tumor concurrently, with the exception of :Patients with in situ
cervical cancer or breast cancer with no evidence of disease for ≥ 3 years after
curative treatments;Patients who underwent successful definitive resection of in
situ cancer with no evidence of disease for ≥5 years;
- Other circumstances that were deemed by the investigator to be inappropriate for
trial participation.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Mengchao Cancer Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Lou jinxing
Start date:
March 7, 2024
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Shanghai Cell Therapy Group Co.,Ltd
Agency class:
Industry
Source:
Shanghai Cell Therapy Group Co.,Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06327997