LCAR-B38M-02 Cells in Treating Relapsed/Refractory (R/R) Multiple Myeloma (LEGEND-2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03090659|
Recruitment Status : Enrolling by invitation
First Posted : March 27, 2017
Last Update Posted : January 24, 2018
Nanjing Legend Biotech Co.
Second Affiliated Hospital of Xi'an Jiaotong University
Jiangsu Provincial People's Hospital
Shanghai Changzheng Hospital
Information provided by (Responsible Party):
Nanjing Legend Biotech Co.
This is a single arm, open-label, multi-center, phase 1/2 study, to determine the safety and efficacy of LCAR-B38M CAR-T cells in treating patients diagnosed with refractory/relapsed multiple myeloma (r/r MM).
|Condition or disease||Intervention/treatment||Phase|
|Refractory or Relapsed Multiple Myeloma||Biological: LCAR-B38M CAR-T cell injection||Phase 1 Phase 2|
Multiple myeloma (MM) is a usually incurable malignancy of plasma cells. Current therapies for multiple myeloma often cause remissions, but nearly all patients eventually relapse and die, an clear unmet clinical needs. As early as mid-2014, the investigators have started to develop a series of proprietary CAR-T products to target B cell maturation antigen (BCMA), a cell surface molecule which the investigator believes to be a desirable target antigen for multiple myeloma. All pre-clinical data and CMC data for LCAR-B38M CAR-T cell technology has been established by mid-2015 and a phase I proof-of-concept clinical trial has been planned since then.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Study of Legend Biotech BCMA-chimeric Antigen Receptor Technology in Treating Relapsed/Refractory (R/R) Multiple Myeloma Patients|
|Actual Study Start Date :||October 2, 2015|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||December 1, 2019|
Experimental: LCAR-B38M treatment group
r/r multiple myeloma patients be treated with a split doses of LCAR-B38M cells. Total dose of 0.5-5 millions /kg cells will be administered at day 0, day 2 and day 6 by split dose (20%, 30% and 50% respectively).
|Biological: LCAR-B38M CAR-T cell injection|
Primary Outcome Measures :
- Occurrence of treatment related adverse events as assessed by CTCAE v4.0 [ Time Frame: Day 1-30 days after injection ]>= Grade 1 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment
Secondary Outcome Measures :
- Anti-myeloma responses to LCAR-B38M cell treatment [ Time Frame: Day 1-36 months after three split doses ]by measuring the changes of aberrant immunoglobulin in serum
- Anti-myeloma responses to LCAR-B38M cell treatment [ Time Frame: Day 1-36 months after three split doses ]multiple myeloma cells in bone marrow.
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