LCAR-B4822M-02 Cells in Treating Relapsed/Refractory (R/R) Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT03674463|
Recruitment Status : Unknown
Verified September 2018 by Second Affiliated Hospital of Xi'an Jiaotong University.
Recruitment status was: Active, not recruiting
First Posted : September 17, 2018
Last Update Posted : December 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Refractory or Relapsed Multiple Myeloma||Drug: LCAR-B4822M CAR-T Cell Immunotherapy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||LCAR-B4822M-02 Cells in Treating Relapsed/Refractory (R/R) Multiple Myeloma|
|Actual Study Start Date :||July 26, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: LCAR-B4822M treatment group
r/r multiple myeloma patients will be treated with LCAR-B4822M CAR-T cells with a escalation approach, 0.5x10^6- 2.0x10^6 CAR-T cells/kg.
Drug: LCAR-B4822M CAR-T Cell Immunotherapy
Patients will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of CAR-T cells. After a pre-treatment lymphodepletion therapy, patients will receive the LCAR-B4822M CAR-T Cell Immunotherapy by intravenous injection.
- Occurrence of treatment related adverse events [ Time Frame: Day 1-30 days after injection ]Assessed by CTCAE v4.0
- Anti-myeloma responses to LCAR-B4822M cell treatment [ Time Frame: Day 1-36 months after injection ]by measuring the changes of aberrant immunoglobulin in serum
- Anti-myeloma responses to LCAR-B38M cell treatment [ Time Frame: Day 1-36 months after injection ]multiple myeloma cells in bone marrow
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): NCT03674463
|Second Affiliated Hospital of Xi'an Jiaotong University|
|Xi'an, Shaanxi, China, 710000|
|Principal Investigator:||Wan-Hong Zhao, MD, PhD||Second Affiliated Hospital of Xi'an Jiaotong University|