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.
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|ClinicalTrials.gov Identifier: NCT03545815|
Recruitment Status : Recruiting
First Posted : June 4, 2018
Last Update Posted : June 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor, Adult||Biological: anti-mesothelin CAR-T cells||Phase 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.
- To evaluate the duration of 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 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.|
|Actual Study Start Date :||March 1, 2018|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||June 30, 2019|
Experimental: anti-mesothelin CAR-T cells
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.
Patients receive anti-mesothelin-CAR T cells on days 0, 1, 2 in the absence of disease progression or unacceptable toxicity.
Biological: anti-mesothelin CAR-T cells
Cells will be infused 1 day after the completion of conditioning regimen.
- study of related adverse events [ Time Frame: 24 weeks ]Grade 3 signs/symptoms, toxicities and clinical
- clinical responses to anti-mesothelin cell infusions [ 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): NCT03545815
|Contact: Wweidong Han, Dr.||firstname.lastname@example.org|
|Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital||Recruiting|
|Beijing, China, 100853|
|Contact: Weidong Han 86-10-13651392893 email@example.com|