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New treatment option for Solid Tumor
Official title An Exploratory Study by Fast CAR T Cells
ClinicalTrials.gov ID: NCT06327997
What this study is testing
What is Fast CAR T cells?
Fast CAR T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Patients diagnosed with advanced solid tumors through histopathological diagnosis have a positive rate of ≥ 50% for mesothelin expression membrane...
- Late stage malignant solid tumor patients who have failed standard treatment or are intolerant to such treatment and do not have a standard effective...
- 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；
You likely can't join if
- people who have undergone other anti-tumor treatments (including radiation therapy, chemotherapy, small molecule, biological or immunotherapy, and...
- 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...
- 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...
See the full eligibility 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...
- 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：
- 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...
- 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...
- International normalized ratio (INR) or the PT is not greater than one and one half times (≤ 1.5) the upper limit of normal;
- Lung function: ≤ CTCAE grade 1 dyspnea and SaO2≥ 91%；
- Cardiac function: cardiac ejection fraction (LVEF) must be greater than fifty percent (≥50%) by echocardiogram or MUGA one month before enrollment.
- people must have measureable disease as defined by RECIST 1.1 criteria;
- people sufficiently understand the trial and willingly sign the informed consent；
- Male and Female people 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...
- people 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- Other circumstances that were deemed by the investigator to be inappropriate for trial participation.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.