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Exploratory Study of MSLN-CAR T Cells Secreting PD1/CTLA-4 Nanoantibody for the Treatment of Advanced Solid Tumors

NCT06248697 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-02-08

No results posted yet for this study

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 and CTLA-4 nanobodies (αPD1/CTLA-4-MSLN-CAR T cells) in patients with solid tumors.

Conditions

Interventions

BIOLOGICAL

αPD1/CTLA4-MSLN-CAR T cells

BZE2209 is prepared by non-viral vector technology consisting of autologous CD3+T cells expressing mesothelin-specific chimeric antigen receptor (CAR), PD1 nanoantibody and CTLA4 antibody with dimethyl sulfoxide as medium. It can be used for direct intravenous infusion. Autologous CD3+ T cells were transfected with plasmids expressing anti-mesothelin-specific CAR, anti-PD1 nanoantibody and anti-CTLA-4 antibody by electroporation in vitro. Mesothelin-specific CAR is a single-domain antibody (VHH) derived from alpaca, which is composed of a binding domain and a CD28 and CD3ζ chain signal transduction domain.

Sponsors & Collaborators

  • Shanghai Cell Therapy Group Co.,Ltd

    lead INDUSTRY

Principal Investigators

  • Jinxing Lou · Shanghai Mengchao Cancer 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
2023-01-01
Primary Completion
2026-07-30
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06248697 on ClinicalTrials.gov