Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T for Refractory/Relapsed B Cell Lymphoma.
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|ClinicalTrials.gov Identifier: NCT03929107|
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|B Cell Lymphoma||Biological: Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T cells||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Interleukin-7 and Chemokine (C-C Motif) -Ligand 19-expressing CD19-CAR-T for Refractory/Relapsed B Cell Lymphoma|
|Actual Study Start Date :||March 28, 2019|
|Estimated Primary Completion Date :||January 31, 2022|
|Estimated Study Completion Date :||April 30, 2022|
Experimental: Intervention group
In this group, patients will be treated with Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T, and the safety and efficacy will be evaluated.
Biological: Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T cells
patient's T cells were seperated and engineered into Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T cells, and retransfused into the patient for treatment of their B cell lymphoma.
- complete remission rate [ Time Frame: at the time point 3 months after CAR-T cell transfusion ]complete remission rate after treated by CAR-T therapy
- adverse events [ Time Frame: from the date of the start of treatment to 24 months after last patient's enrollment ]any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
- progression free surviva [ Time Frame: from the day of treatment to the date of first documented progression，up to 24 months after the last patient's enrollment ]from date of inclusion to date of progression, relapse, or death from any cause
- overall survival [ Time Frame: from the day of treatment to the date of first documented progression，up to 24 months after the last patient's enrollment ]from the date of inclusion to date of death, irrespective of cause
- duration of the CAR-T cells in the patients [ Time Frame: from the date of re-transfusison to 24 months after last patient's enrollment ]time from re-transfusion to date when the modified T cells become non-detectable.
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): NCT03929107
|Contact: Juying Wei, MD||(+86)email@example.com|
|Contact: Hui Liu, MD,PhD||(+86)13819198629|
|The first affiliated hospital of Zhejiang University||Recruiting|
|Hangzhou, Zhejiang, China, 310000|
|Contact: Wenbin Qian, MD,PhD (+86)13605801032 firstname.lastname@example.org|
|Principal Investigator:||Wenbin Qian, MD，PhD||Zhejiang University|