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αPD1-MSLN-CAR T Cells for the Treatment of MSLN-positive Advanced Solid Tumors | Clinical Trials | Clareo Health

UNKNOWNEARLY_PHASE1

αPD1-MSLN-CAR T Cells for the Treatment of MSLN-positive Advanced Solid Tumors

An Exploratory Study of αPD1-MSLN-CAR T Cells Secreting PD-1 Nanobodies for the Treatment of MSLN-positive Advanced Solid Tumors

NCT04503980•Shanghai Cell Therapy Group Co.,Ltd

View on ClinicalTrials.gov

Summary

This is a single arm, open-label, dose escalation clinical study to evaluate the safety and tolerability of autologous mesothelin (MSLN)-targeted chimeric antigen receptor (MSLN-CAR) T cells secreting PD-1 nanobodies (αPD1-MSLN-CAR T cells) in patients with solid tumors.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must have a histological or cytological diagnosis of advanced solid tumors, such as ovarian cancer，Cholangiocarcinoma，colorectal cancer;
•Patients must have failed established standard medical anti-cancer therapies；
•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;
•Subjects must meet blood coagulation parameters and have adequate venous peripheral access for apheresis. Patients must also have adequate mononuclear cells for CAR T cell manufacturing；
•Staining of MSLN must be greater than 50% of the cells in the tumor tissue and with apparent expression in the membrane. PD-L1 expression must be positive. Tissue obtained for the biopsy must be ≤1 year prior to enrollment for screening, not have been previously irradiated or exposed to chemotherapy. If unavailable, new tissue material from a recently obtained surgical or diagnostic biopsy is mandatory for this trial；
•Satisfactory organ and bone marrow function as defined by the following:
•1. Adequate bone marrow function in the opinion of the Investigator for lymphocyte-depleting chemotherapy: absolute neutrophil count must be greater than ≥ 1.5×109/L, lymphocyte count must be greater than ≥ 0.5×109/L, platelets must be greater than ≥ 90×109/L, hemoglobin must be greater than ≥ 90g/L without transfusion within 7 days or dependency on EPO;
•2. 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 to 2.5 times (≤2.5x) the institutional normal upper limit (≤2.5x if there is hepatic metastasis);
+10 more criteria

Exclusion Criteria

•Prior therapy with targeted therapy or cell therapy against MSLN；
•Prior therapy with any gene therapy (including CAR-T cell therapy) or any T cell therapy home and abroad；
•Active bacteria, viral or fungal infection, and not contained after anti-infective therapy (positive results in the blood ≤72 hours before infusion);
•Patient is positive for Syphilis, Human Immunodeficiency Virus (HIV) , active Hepatitis B (HBsAg reactive) or Hepatitis C (HCV RNA (qualitative) is detected);
•Patient has a medical condition such as autoimmune disease or organ transplantation that requires chronic systemic steroid therapy or requires any other form of immunosuppressive medication;
•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 Association functional classification ≥3), cardiac angioplasty and stents, myocardial infarction, unstable angina, or other clinically significant heart disease；
•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 system；
•Patient has a history or current evidence of any condition such as neurotic, psychiatric, immune, metabolic and infectious disease, on any therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator；
•Patient has a known history of a hematologic malignancy, or of another malignant primary solid tumor concurrently, with the exception of :
•1. Patients with in situ cervical cancer or breast cancer with no evidence of disease for ≥ 3 years after curative treatments;
+4 more criteria

Locations (1)

Shanghai Tenth people's Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

March 26, 2020

Primary Completion Date

March 1, 2021

Completion Date

June 1, 2022

Last Updated

August 7, 2020

Enrollment

ESTIMATED participants

Conditions

Colorectal CancerOvarian Cancer

Interventions

αPD1-MSLN-CAR T cells

BIOLOGICAL

Contacts

Juemin Fang

CONTACT

021-66302521 435254611@qq.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 7, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

αPD1-MSLN-CAR T Cells for the Treatment of MSLN-positive Advanced Solid Tumors

Inclusion Criteria

Exclusion Criteria

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