BCMA Nano Antibody CAR-T Cells for Patients With Refractory and Relapsed Multiple Myeloma (BCMA CAR-T)
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|ClinicalTrials.gov Identifier: NCT03661554|
Recruitment Status : Unknown
Verified September 2018 by The Pregene (ShenZhen) Biotechnology Company, Ltd..
Recruitment status was: Recruiting
First Posted : September 7, 2018
Last Update Posted : September 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Relapsed and Refractory Multiple Myeloma||Biological: BCMA CAR-T Cells||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||In this study, a 3 + 3 dose gradient climbing design was used. Three dosage groups, 5 x 106 / kg, 1 x 107 / kg and 1.5 x 107 / kg, were divided into three groups.|
|Masking:||None (Open Label)|
|Masking Description:||Clinical study of BCMA nano-antibody CAR-T cells in the treatment of refractory recurrent multiple myeloma (single center, single arm, open clinical study)|
|Official Title:||BCMA Nano Antibody CAR-T Cells for the Treatment of Refractory Relapsed Multiple ,Single Center, Single Arm and Open Clinical Study of Myeloma|
|Actual Study Start Date :||April 10, 2018|
|Estimated Primary Completion Date :||October 30, 2018|
|Estimated Study Completion Date :||November 30, 2018|
Experimental: single arm
This clinical study, "BCMA nano-antibody CAR-T cells in the treatment of refractory recurrent multiple myeloma clinical research," is a single center, single arm, open design. The aim is to study the safety and efficacy of BCMA nano antibody CAR-T in the treatment of MM. In this study, a 3 + 3 dose gradient climbing design was used. Three dosage groups, 5x106 / kg, 1x107 / kg and 1.5x107 / kg, were divided into three groups.
Biological: BCMA CAR-T Cells
The Chinese name of CAR-T cells is chimeric antigen receptor T cells. It is through gene transfection technology, so that patients with T lymphocytes can carry B cell-specific antigens, so that T lymphocytes can selectively kill B lymphocyte-derived tumor cells.
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 2 years ]Any adverse events associated with BCMA nanoscale CAR-T cell therapy during the trial period
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): NCT03661554
|Contact: jishuai zhang, firstname.lastname@example.org|
|Pregene Shenzhen Biotechnology Co., Ltd.||Recruiting|
|Shenzhen, Guangdong, China, 518000|
|Contact: jishuai zhang 13661255147 ext 13661255147 email@example.com|