Anti-CD19/BCMA Bispecific CAR-T Cell Therapy for R/R MM
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|ClinicalTrials.gov Identifier: NCT03706547|
Recruitment Status : Not yet recruiting
First Posted : October 16, 2018
Last Update Posted : October 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma in Relapse Multiple Myeloma Progression||Biological: anti-CD19/BCMA CAR-T cells Drug: Fludarabine Drug: Cyclophosphamide||Phase 1|
1. To determine the feasibility ad safety of anti-CD19/BCMA CAR-T cells in treating patients with BCMA-positive multiple myeloma.
- To access the efficacy of anti-CD19/BCMA CAR-T cells in patients with multiple myeloma.
- To determine in vivo dynamics and persistency of anti-CD19/BCMA CAR-T cells.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study of Anti-CD19/BCMA Bispecific Chimeric Antigen Receptors (CARs) T Cell Therapy for Relapsed and Refractory Multiple Myeloma|
|Estimated Study Start Date :||October 30, 2018|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||December 2021|
Experimental: anti-CD19/BCMA CAR-T cells
Biological: anti-CD19/BCMA CAR-T cells
Retroviral vector-transduced autologous T cells to express anti-CD19 and anti-BCMA CARs
- Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0 [ Time Frame: 6 months ]Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
- Overall remission rate defined by the standard response criteria for myeloma for each arm [ Time Frame: 8 weeks ]Overall remission rate defined by the standard response criteria for myeloma for each arm
- Duration of CAR-positive T cells in circulation [ Time Frame: 6 months ]Duration of CAR-positive T cells in circulation
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): NCT03706547
|Contact: Zheng Wei, M.D.||+(86)-21 64041990 ext email@example.com|
|Department of Hematology ,Fudan University Zhongshan Hospital||Active, not recruiting|
|Shanghai, China, 200032|
|Principal Investigator:||Peng Liu, M.D. & Ph.D.||Shanghai Zhongshan Hospital|