Anti-Mesothelin CAR-T Cell Injection in Patients With Mesothelin-positive Advanced Malignant Soli… (NCT07010523) | Clinical Trial Compass
RecruitingNot Applicable
Anti-Mesothelin CAR-T Cell Injection in Patients With Mesothelin-positive Advanced Malignant Solid Tumors
China24 participantsStarted 2024-10-15
Plain-language summary
This is a single-arm, open-label, exploratory clinical study to evaluate the safety, tolerability and preliminary efficacy of Anti-Mesothelin CAR-T cell injection in patients with Mesothelin-positive advanced malignant solid tumors.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 18 to 75 years old (including cut-off value), gender is not limited.
✓. Solid tumors that histological diagnosis of malignancy refractor 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. Subjects have failed with standard treatment or cannot tolerate treatment recommended by clinical treatment guidelines form relevant international and domestic authoritative organization (Chinese Anti-Cancer Association(CACA), Chinese Society of Clinical Oncology(CSCO), National Health Commission, etc.)
✓. 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
✕. Pregnant or lactating women.
✕
What they're measuring
1
Adverse Events (AEs)
Timeframe: 2 years
2
Serious Adverse Events (SAEs)
Timeframe: 2 years
3
Adverse Events of Special Interest (AESI)
Timeframe: 2 years
4
dentification of Maximum Tolerated Dose (MTD) & Incidence of Dose-limiting Toxicities (DLTs)
. 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 RNA 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.
✕. 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.
✕. Patients with clinically significant systemic disease (such as: severe active infection or significant cardiac, pulmonary, hepatic, nervous system, or other organ dysfunction) that evaluated by the investigator would impair the patients' ability to tolerate the treatments used in this study or significantly increase the risk of complications.