NCT04489862

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

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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

• Non-small-cell Lung Cancer
• Mesothelioma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-05-13
• Primary completion: 2022-06-01
• Completion: 2022-12-01
• First posted: 2020-07-28
• Last updated: 2020-07-28

Locations

1 site across 1 country: China