NCT06249256

An Exploratory Study on the Treatment of Advanced Solid Tumors by Fast CAR T Cells

An Exploratory Study on the Treatment of Advanced Solid Tumors by Secretory PD1 Nanoantibody Targeting Mesothelin Fast CAR T Cells

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Shanghai Cell Therapy Group Co.,Ltd · Industry
• 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 fast autologous mesothelin (MSLN)-targeted chimeric antigen receptor (MSLN-CAR) T cells secreting PD-1 nanobodies in patients with solid tumors.

Detailed description

The main aim of this study is to determin the safety and efficacy of BZT2312 in patients with solid tumors. BZT2312 is an autologous mesothelin (MSLN)-targeted chimeric antigen receptor (MSLN-CAR) T cells secreting PD-1 nanobodies. This study comprises of a screening phase(less than or equal to 28 days prior to apheresis) followed by apheresis(will occur upon enroiiment); Apheresis phase(less than or equal to 10 days prior to infusion ) followed by lymphodepletion. lymphodepletion phase (from day -5 to day -3) followed by infusion.Treatment Phase including infusion of BZT2312 on Day0 and then post-infusion assessments from Day1 to Day 28; and a Post-treatment Phase(Day 29 and up to end of the study). Efficacy will be explored to assessed and safety will be closely monitored during the study.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	Fast CAR T cells	Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of Fast CAR T cells. During Fast CAR T cells production, subjects will receive cyclophosphamide and fludarabine for the purpose of lymphocytes depletion. After lymphodepletion, subjects will receive one dose treatment with Fast CAR T cells by intravenous (IV) injection.

Timeline

• Start date: 2023-06-01
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2024-02-08
• Last updated: 2024-02-08

Locations

1 site across 1 country: China