Novel Autologou CAR-T Therapy for Relapsed/Refractory B Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT03258047|
Recruitment Status : Active, not recruiting
First Posted : August 22, 2017
Last Update Posted : February 15, 2019
It's a single arm, open label prospective study, in which the safety and efficacy of autologous CAR-T are evaluated in refractory/relapsed B cell lymphoma patients.
Abbreviation: CAR-T: Chimeric Antigen Receptor T-Cell Immunotherapy.
|Condition or disease||Intervention/treatment||Phase|
|B Cell Lymphoma||Combination Product: CAR-T||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Novel Autologou CAR-T Therapy for Relapsed/Refractory B Cell Lymphoma|
|Actual Study Start Date :||September 15, 2017|
|Actual Primary Completion Date :||January 13, 2019|
|Estimated Study Completion Date :||July 30, 2019|
Experimental: CAR-T treatment
In this group, patients will be treated with autologous CAR-T, and the safety and efficacy will be evaluated
Combination Product: CAR-T
CAR-T is a novel technique for cancer treatent, it includes procedures of modifying patients' T cells outside the body and re-transfuse these cells back into the human body to fight against the cancer cells.
- complete remission rate [ Time Frame: every 3 months until 20 months after the last patient's enrollment ]complete remission rate after treated by CAR-T therapy
- progression free survival [ Time Frame: from the day of treatment to the date of first documented progression，up to 20 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: 20 months after the last patient's enrollment ]from the date of inclusion to date of death, irrespective of cause
- adverse events [ Time Frame: from the date of the start of treatment to 20 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
- duration of the modified T cells by CAR-T in the patients [ Time Frame: from the date of re-transfusison to 20 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): NCT03258047
|The first affiliated hospital of Zhejiang University|
|Hangzhou, Zhejiang, China, 310000|