NCT03525782

Anti-MUC1 CAR T Cells and PD-1 Knockout Engineered T Cells for NSCLC

A Clinical Study of Anti-MUC1 CAR T Cells and PD-1 Knockout Engineered T Cells for Patients With Advanced Non-small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: The First Affiliated Hospital of Guangdong Pharmaceutical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The study is to assess the safety and efficacy of the anti-MUC1 CAR T cells and /or PD-1 knockout engineered T cells for patients with advanced non-small cell lung cancer.

Detailed description

This is a combined phase 1 and 2 clinical study. The study is to assess the safety and efficacy of the anti-MUC1 CAR T cells and /or PD-1 knockout engineered T cells for patients with advanced non-small cell lung cancer. The treatment outcomes will be compared.

Conditions

• Lung Neoplasm Malignant
• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	CAR-T Cells	Using the T cells from the patients to produce anti-MUC1 CAR-T Cells and then the cells will be infused back to the patients.
COMBINATION_PRODUCT	CAR-T combining PD-1 Knockout	Using the T cells from the patients to prepare anti-MUC1 CAR-T Cells and PD-1 knockout T cells, then the cells will be infused back to the patients
BIOLOGICAL	PD-1 knockout	Using the T cells from the patients to prepare PD-1 knockout T cells, then the cells will be infused back to the patients
DRUG	PD-1 mAb	Patients will be treated with an identical course with a FDA approved monoclonal antibody against PD-1
OTHER	Sham control	Patient's T cell will treated ex vivo with modification and then infused back in a similar time course.

Timeline

• Start date: 2018-02-01
• Primary completion: 2021-01-31
• Completion: 2022-01-31
• First posted: 2018-05-16
• Last updated: 2018-05-16

Locations

3 sites across 1 country: China