Study of PD-1 Gene-knocked Out Mesothelin-directed CAR-T Cells With the Conditioning of PC in Mesothelin Positive Multiple Solid Tumors
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|ClinicalTrials.gov Identifier: NCT03747965|
Recruitment Status : Recruiting
First Posted : November 20, 2018
Last Update Posted : November 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor, Adult||Biological: Mesothelin-directed CAR-T cells||Phase 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.
- To evaluate the duration and in vivo persistence of transferred CAR-T cells.
- To observe and measure anti-tumor responses for patients with detectable mesothelin positive tumor lesions.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Estimated Study Start Date :||November 2018|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||May 2020|
Experimental: Mesothelin-directed CAR-T cells infusion
Patients receive mesothelin-directed CAR-T cells infusion with dose escalation will occur using a standard "3+3" dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation.
Biological: Mesothelin-directed CAR-T cells
Cells will be infused one day after the completion of conditioning regimen of paclitaxel and cyclophosphamide
- Study of related adverse events [ Time Frame: 24 weeks ]Grade 3 or severer signs/symptoms, toxicities and clinical
- Clinical responses of mesothelin-directed CAR T cells infusion [ Time Frame: 24 weeks ]Disease control rate(DCR)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03747965
|Contact: Weidong Han, Dremail@example.com|
|Chinese PLA General Hospital||Recruiting|
|Beijing, Beijing, China, 100853|
|Contact: Weidong Han, Dr 86-10-13651392893 firstname.lastname@example.org|
|Study Director:||Weidong Han, Dr||Chinese PLA General Hospital|