NCT03747965

Study of PD-1 Gene-knocked Out Mesothelin-directed CAR-T Cells With the Conditioning of PC in Mesothelin Positive Multiple Solid Tumors

Phase I Study of CRISPR-Cas9 Mediated PD-1 Gene-knocked Out Mesothelin-directed CAR-T Cells With the Conditioning Regimen of Paclitaxel and Cyclophosphamide in 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, the investigators use the technique of CRISPR-Cas9 to knocked out the PD-1 of the chimeric antigen receptor (CAR) T cells with the combination of Pretreatment by Paclitaxel and Cyclophosphamideto to effect the immuno-microenvironment around tumors.

Detailed description

1. To evaluate the feasibility and safety of CRISPR-Cas9 mediated PD-1 gene-knocked out chimeric antigen receptor (CAR) T cells in patients with mesothelin positive multiple solid tumors. 2. To evaluate the duration and 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	Mesothelin-directed CAR-T cells	Cells will be infused one day after the completion of conditioning regimen of paclitaxel and cyclophosphamide

Timeline

• Start date: 2018-11-01
• Primary completion: 2019-11-01
• Completion: 2020-05-01
• First posted: 2018-11-20
• Last updated: 2018-11-20

Locations

1 site across 1 country: China