This study aims to explore the safety, tolerability and preliminary efficacy of Anti-Mesothelin CAR-T cells in subjects with Mesothelin-positive advanced malignant solid tumors.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject is≥18 years old (including cut-off value), gender is not limited
✓. Solid tumors that histological diagnosis of malignancy refractory to, or relapsing after standard therapy, including but not limited to mesothelioma, pancreatic cancer, biliary tract cancer, lung cancer, ovarian cancer, gastric cancer, bowel cancer, thymic carcinoma, esophageal cancer, breast cancer, endometrial cancer.
✓. At least one measurable lesion according to RECIST v1.1.
✓. Mesothelin should be positive confirmed by Immunohistochemistry/Immunocytochemistry (IHC/ICC) in tumor tissue samples.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓. Life expectancy ≥ 3 months.
✓. Adequate function defined as:
✓. Female participants of childbearing potential must undergo a pregnancy test and the results must be negative. Female participants of childbearing potential or male participants whose sex partner has childbearing potential must be willing to use effective methods of contraception from screening period to at least 1 year after infusion.
Exclusion criteria
✕. Patients have received systemic therapy with cytotoxic chemicals, monoclonal antibodies, or immunotherapy within 4 weeks or 5 half-lives (which is shorter) prior to signing informed consent; Patients have received systemic glucocorticoids (prednisone at a dose of ≥10 mg per day or equivalent) or other immune-suppressive therapy within 2 weeks prior to signing informed consent; Patients have received systemic antitumor therapy with a biologic agent or other approved targeted small-molecule inhibitor within 1 week or five half-lives (which is shorter) prior to signing informed consent; Patients have received Chinese herbal medicine or Chinese patent medicine with anti-tumor indication within 1 week prior to signing informed consent.
✕. Pregnant or lactating women.
✕. Patients with hepatitis B surface antigen (HBsAg) positive. Patients who is hepatitis B core antibody (HBcAb) positive and the quantification of HBV DNA in peripheral blood is higher than the lower limit of detection. Patients who is hepatitis C virus (HCV) antibody positive and quantification of HCV DNA in peripheral blood is higher than the lower limit of detection. Patients with human immunodeficiency virus (HIV) antibody positive, or syphilis antibody positive.
✕. The toxicities caused by the prior therapy (surgery, chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) have not recovered to grade 1 according to CTCAE, except for hair loss and peripheral sensory nerve disorders.
✕. Have received any allogeneic tissue/organ transplantation (including bone marrow transplantation, stem cell transplantation, liver transplantation, kidney transplantation), except for the transplantation that does not require immunosuppressive therapy (such as: corneal transplantation, hair transplantation.)
✕. Patients have received anti-mesothelin CAR-T cell therapy.
✕. Patients who have history of major surgery and unrecovered severe trauma within 4 weeks prior to signing informed consent; or plan to have major surgery within 12 weeks of cell therapy.
What they're measuring
1
Adverse Events (AEs)
Timeframe: 2 years
2
Serious Adverse Events
Timeframe: 2 years
3
Adverse Events of Special Interest (AESI)
Timeframe: 2 years
4
Identification of Maximum Tolerated Dose (MTD) & Incidence of Dose-limiting Toxicities (DLTs)
Timeframe: 4 weeks after the CAR-T cells infusion
Trial details
NCT IDNCT05783089
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
. Presence of known central nervous system metastases, but the following patients will be allowed: a) Asymptomatic brain metastases; b) Clinically stable (no radiographic progression within 4 weeks before apheresis and return of any neurologic symptoms to baseline), and with no need for corticosteroids or other treatment for brain metastases for ≥ 4 weeks.