αPD1-MSLN-CAR T Cells for the Treatment of MSLN-positive Advanced Solid Tumors
NCT04503980 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2020-08-07
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.
Conditions
Interventions
- 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. 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.
Sponsors & Collaborators
-
Shanghai 10th People's Hospital
collaborator OTHER -
Shanghai Cell Therapy Group Co.,Ltd
lead INDUSTRY
Principal Investigators
-
Qing Qu · Shanghai 10th People's Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-03-26
- Primary Completion
- 2021-03-31
- Completion
- 2022-06-30
Countries
- China
Study Locations
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