Exploratory Study of Novel MSLN CAR-T Cell Therapy in Patients With MSLN-positive Advanced Refrac… (NCT05531708) | Clinical Trial Compass
WithdrawnPhase 1
Exploratory Study of Novel MSLN CAR-T Cell Therapy in Patients With MSLN-positive Advanced Refractory Solid Tumors
Stopped: The study is not initiated and we want it to be withdrawn.
China0Started 2021-04-02
Plain-language summary
This is a single-arm, open-label, exploratory clinical study to evaluate the safety and efficacy of novel Mesothelin CAR-T in patients with Mesothelin-positive advanced refractory solid tumors.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Solid tumors positive for the Mesothelin antigen by Immunohistochemistry/Immunocytochemistry (IHC/ICC); histological diagnosis of malignancy refractory to, or relapsing after standard therapy.
✓. At least one measurable lesion according to RECIST v1.1.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓. Adequate hepatic, renal, cardiac and coagulation function defined as:
✓. Negative screen for infectious disease markers including HIV-Ab, HCV-Ab, HBeAg, HBsAg, and syphilis. Note - Participants with history of prior HBV infection are eligible if the HBV viral load is undetectable. Participants with a history of HCV infection who were treated for hepatitis C and cured are eligible if hepatitis C viral load is undetectable.
✓. The toxicities from any prior therapy must have recovered to a grade 1 or less (except for toxicities such as alopecia or vitiligo) according to NCI CTCAE v5.0.
Exclusion criteria
✕. Patients with central nervous system involvement.
✕. 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 patient's ability to tolerate the treatments used in this study or significantly increase the risk of complications.
✕. Any known or suspected autoimmune disease; or active, chronic or recurrent immune-mediated disease (within one year prior to enrollment) requiring steroid or other immunosuppressive therapy.
✕. History of severe systemic hypersensitivity reaction to the drugs/ingredients used in this study.
✕. 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.)
✕. Have received any genetic engineering modified T cell therapy (including CAR-T, TCR-T).
✕. History of major surgery and unrecovered severe trauma within 4 weeks prior to signing informed consent.
✕. History of another malignancy tumor, except for non-melanoma skin cancer and carcinoma in situ of bladder, stomach, colon, cervix/dysplasia, melanoma, or breast.