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 : Unknown
Verified August 2020 by Han weidong, Chinese PLA General Hospital.
Recruitment status was: Recruiting
First Posted : June 4, 2018
Last Update Posted : August 10, 2020
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Tracking Information | |||||
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First Submitted Date ICMJE | May 23, 2018 | ||||
First Posted Date ICMJE | June 4, 2018 | ||||
Last Update Posted Date | August 10, 2020 | ||||
Actual Study Start Date ICMJE | March 19, 2018 | ||||
Estimated Primary Completion Date | October 30, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
study of related adverse events [ Time Frame: 24 weeks ] Grade 3 signs/symptoms, toxicities and clinical
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
clinical responses to anti-mesothelin cell infusions [ Time Frame: 24 weeks ] Disease control rate(DCR)
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | 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. | ||||
Official Title ICMJE | 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. | ||||
Brief 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 |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Solid Tumor, Adult | ||||
Intervention ICMJE | Biological: anti-mesothelin CAR-T cells
Cells will be infused on day 0.
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Study Arms ICMJE | 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 day 0. Intervention: Biological: anti-mesothelin CAR-T cells
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
10 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 30, 2020 | ||||
Estimated Primary Completion Date | October 30, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03545815 | ||||
Other Study ID Numbers ICMJE | CHN-PLAGH-BT-028 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Han weidong, Chinese PLA General Hospital | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Chinese PLA General Hospital | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Chinese PLA General Hospital | ||||
Verification Date | August 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |