Exploratory Study of Novel MSLN CAR-T Cell Therapy in Patients With MSLN-positive Advanced Refractory Solid Tumors

Safety and Efficacy Study of Novel Mesothelin CAR-T Cell Therapy in Patients With Mesothelin-positive Advanced Refractory Solid Tumors

NCT05531708•Shanghai Pudong Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Solid tumors positive for the Mesothelin antigen by Immunohistochemistry/Immunocytochemistry (IHC/ICC); histological diagnosis of malignancy refractory to, or relapsing after standard therapy.
•2. At least one measurable lesion according to RECIST v1.1.
•3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
•4. Life expectancy ≥ 3 months.
•5. Neutrophils ≥ 1.0×10\^9/L; Lymphocytes ≥ 0.5×10\^9/L; Hemoglobin ≥ 80 g/L; Platelets ≥ 75×10\^9/L.
•6. Adequate hepatic, renal, cardiac and coagulation function defined as:
•* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN); patients with liver metastasis must be ≤ 5 × ULN;
•* Total bilirubin (TBIL) ≤ 1.5 × ULN; TBIL of patients with Gilbert's Syndrome must less than 3.0 mg/dL;
•* Serum creatinine (Cr) ≤ 1.5 × ULN, and creatinine clearance rate (Ccr) ≥ 60 mL/min;
•* Left ventricular ejection fraction (LVEF) \> 45%;
+7 more criteria

Exclusion Criteria

•1. Patients with central nervous system involvement.
•2. 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.
•3. 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.
•4. History of severe systemic hypersensitivity reaction to the drugs/ingredients used in this study.
•5. 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.)
•6. Have received any genetic engineering modified T cell therapy (including CAR-T, TCR-T).
•7. History of major surgery and unrecovered severe trauma within 4 weeks prior to signing informed consent.
•8. History of another malignancy tumor, except for non-melanoma skin cancer and carcinoma in situ of bladder, stomach, colon, cervix/dysplasia, melanoma, or breast.
•9. History of neuropsychiatric diseases diagnosed by the ICD-11 criteria or evaluated by investigator.
•10. For any other reasons, the patients are believed not suitable for participation in this study by investigators.

Locations (1)

Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

April 2, 2021

Primary Completion Date

April 30, 2025

Completion Date

April 30, 2026

Last Updated

March 1, 2023

Conditions

Mesothelin-positive Advanced Refractory Solid Tumors

Interventions

Anti-mesothelin CAR-T cells

BIOLOGICAL

Fludarabine

DRUG

Cyclophosphamide

DRUG