αPD1-MSLN-CAR T Cells for the Treatment of MSLN-positive Advanced Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04489862|
Recruitment Status : Recruiting
First Posted : July 28, 2020
Last Update Posted : July 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Non-small-cell Lung Cancer Mesothelioma||Biological: αPD1-MSLN-CAR T cells||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Exploratory Study of MSLN-CAR T Cells Secreting PD-1 Nanobodies for the Treatment of MSLN-positive Advanced Solid Tumors|
|Actual Study Start Date :||May 13, 2020|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||December 2022|
Experimental: CAR T cells therapy
The safety and efficacy of αPD1-MSLN-CAR T cells will be assessed in a standard 3+3 dose escalation approach. Four doses of CAR T cells will be evaluated in this study: 1×10^5 CAR+ T cells/kg, 3×10^5 CAR+ T cells/kg, 1×10^6 CAR+ T cells/kg, and 3×10^6 CAR+ T cells/kg.
Biological: αPD1-MSLN-CAR T cells
Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of αPD1-MSLN-CAR T cells. During αPD1-MSLN-CAR T cells production, subjects will receive cyclophosphamide for the purpose of lymphocytes depletion，Cyclophosphamide 300 mg/m2/day IV infusion on days -5, -4 and -3. After lymphodepletion, subjects will receive one dose treatment with αPD1-MSLN-CAR T cells by intravenous (IV) injection. The initial dose of 1×10^5 CAR+ T cells/kg will be infused on day 0.
- Dose-limiting toxicity （DLT） [ Time Frame: After 28 days of single infusion ]Safety
- Maximum tolerated dose (MTD) [ Time Frame: After 28 days of single infusion ]Tolerability
- Objective response rate (ORR) [ Time Frame: Month 12 ]Clinical response will be assessed by RECIST 1.1.
- Progression-free survival (PFS) [ Time Frame: Month 12 ]PFS of patients receiving αPD1-MSLN-CAR T cells
- Overall survival (OS) [ Time Frame: Month 12 ]OS of patients receiving αPD1-MSLN-CAR T cells.
- Peak Plasma Concentration (Cmax) [ Time Frame: Month 12 ]Pharmacokinetics (PK
- Pharmacodynamics (PD) [ Time Frame: Day 28 ]PD of IL-2, IL-4, IL-6, IL-8, IL-10, IL-15, IFN-γ, TNF-α and MCP1 will be analysed after CAR T cell infusion
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04489862
|Contact: Lu Wenemail@example.com|
|Contact: Xiaoli Lufirstname.lastname@example.org|
|Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology||Recruiting|
|Wuhan, Hubei, China, 430000|
|Contact: Lu Wen 027-85872589 email@example.com|
|Principal Investigator:||Xiaorong Dong||Wuhan Union Hospital, China|