PD-1 Antibody Expressing CAR-T Cells for EGFR Family Member Positive Advanced Solid Tumor
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|ClinicalTrials.gov Identifier: NCT02873390|
Recruitment Status : Unknown
Verified August 2016 by Ningbo Cancer Hospital.
Recruitment status was: Recruiting
First Posted : August 19, 2016
Last Update Posted : October 7, 2016
To evaluate the safety and effectiveness of cell therapy using herinCAR-PD1 cells to treat advanced cancer.
Individuals greater than or equal to 18 years of age and less than or equal to 70 years of age who have been diagnosed with relapsed or refractory cancer that has not responded to or has relapsed after standard treatment.
|Condition or disease||Intervention/treatment||Phase|
|PD-1 Antibody CAR-T Cells Advanced Malignancies||Biological: HerinCAR-PD1 cells||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Study of PD-1 Antibody Expressing CAR-T Cells for EGFR Family Member Positive Advanced Solid Tumor|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||July 2018|
Experimental: HerinCAR-PD1 cells
Patients will receive 3 cycles of HerinCAR-PD1 cells treatment.
Biological: HerinCAR-PD1 cells
herinCAR-PD1 cells transfusion: (1-5×107/kg herinCAR-PD1 + physiological saline + 0.25% human alloalbumin) 300ml for each infusion. IV (in the vein) for each infusion, 2 cycles, each cycle received one infusions on day 21, 43.
- Objective response rate (ORR) [ Time Frame: 2 years ]
- Disease control rate,(DCR) [ Time Frame: 2 years ]
- Overall survival [ Time Frame: 2 years ]
- Progress-free survival(PFS) [ Time Frame: 2 years ]
- Quality of life [ Time Frame: 2 years ]Questionnaire will be used.
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): NCT02873390
|Contact: Bi Wangfirstname.lastname@example.org|
|Ningbo No.5 Hospital (Ningbo Cancer Hospital)||Recruiting|
|Ningbo, Zhejiang, China|
|Contact: Bi Wan 86-13310088259 email@example.com|
|Contact: Jiangtao Wang 86-15888102792|
|Study Director:||Jiangtao Wang||Ningbo No.5 Hospital (Ningbo Cancer Hospital)|
|Study Chair:||Huajun Jin||Shanghai Cell Therapy Research Institute|
|Study Chair:||Qijun Qian||Shanghai Cell Therapy Research Institute|