NCT03545815

Study of CRISPR-Cas9 Mediated PD-1 and TCR Gene-knocked Out Mesothelin-directed CAR-T Cells in Patients With Mesothelin Positive Multiple Solid Tumors.

Phase I Study to Evaluate Treatment of CRISPR-Cas9 Mediated PD-1 and TCR Gene-knocked Out Chimeric Antigen Receptor (CAR) T Cells in Patients With Mesothelin Positive Multiple Solid Tumors.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Multiple solid tumors have positive targets of mesothelin expressed on the surfaces of the tumor cells, we use the technique of CRISPR-Cas9 to knocked out the PD-1 and TCR of chimeric antigen receptor (CAR) T cells to effect the immuno-microenvironment around tumors.

Detailed description

1. To evaluate the feasibility and safety of CRISPR-Cas9 mediated PD-1 and TCR gene-knocked out chimeric antigen receptor (CAR) T cells in patients with mesothelin positive multiple solid tumors. 2. To evaluate the duration of in vivo persistence of transferred CAR-T cells. 3. To observe and measure anti-tumor responses for patients with detectable mesothelin positive tumor lesions.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
BIOLOGICAL	anti-mesothelin CAR-T cells	Cells will be infused on day 0.

Timeline

• Start date: 2018-03-19
• Primary completion: 2020-10-30
• Completion: 2020-12-30
• First posted: 2018-06-04
• Last updated: 2020-08-10

Locations

1 site across 1 country: China