A Study of LCAR-B38M CAR-T Cells, a Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Chinese Participants With Relapsed or Refractory Multiple Myeloma

Last updated: September 1, 2025
Sponsor: Nanjing Legend Biotech Co.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Cancer/tumors

Bone Neoplasm

Red Blood Cell Disorders

Treatment

LCAR-B38M CAR-T Cell

Clinical Study ID

NCT03758417
CR108494
68284528MMY2002
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy and safety of LCAR-B38M chimeric antigen receptor T (CAR-T) cells.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Documented initial diagnosis of multiple myeloma according to International MyelomaWorking Group (IMWG) diagnostic criteria

  • Measurable disease at Screening

  • Received at least 3 prior lines of treatment for multiple myeloma a) Undergone at least 1 complete cycle of treatment for each line, unlessprogressive disease (PD) was documented by IMWG criteria as the best response to theregimen

  • Received a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD)

  • Participant must have documented evidence of progressive disease based oninvestigator's determination of response consistent with IMWG criteria on or within 12 months of their last regimen. Non-responsive disease is defined as either failureto achieve minimal response or development of progressive disease (PD) while ontherapy. Also, participants with documented evidence of PD disease (as above) withinthe previous 6 months and who are refractory or non-responsive to their most recentline of treatment afterwards are eligible

  • Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1

Exclusion

Exclusion Criteria:

  • Prior treatment with chimeric antigen receptor T (cells) CAR-T therapy directed atany target

  • Any therapy that is targeted to B-cell maturation antigen (BCMA)

  • The following cardiac conditions: a) New York Heart Association (NYHA) stage III orIV congestive heart failure b) Myocardial infarction or coronary artery bypass graft (CABG) 6 months prior to enrollment c) History of clinically significant ventriculararrhythmia or unexplained syncope, not believed to be vasovagal in nature or due todehydration d) History of severe non-ischemic cardiomyopathy e) Impaired cardiacfunction (left ventricular ejection fraction [LVEF] less than [<]45%) as assessed byechocardiogram or multiple-gated acquisition (MUGA) scan (performed less than orequal to (<=) 8 weeks of apheresis)

  • Have received a cumulative dose of corticosteroids equivalent to greater than orequal to(>=)70 milligram (mg) of prednisone within 7 days prior to apheresis

  • Diagnosed or treated for invasive malignancy other than multiple myeloma, except:

  1. Malignancy treated with curative intent and with no known active diseasepresent for greater than or equal to (>=) 2 years before enrollment; or

  2. Adequately treated non-melanoma skin cancer without evidence of disease

  • Prior antitumor therapy with insufficient washout period

  • Toxicity from previous anticancer therapy must resolve to baseline levels or toGrade 1 or less except for alopecia or peripheral neuropathy

  • Received either of the following:

  1. An allogeneic stem cell transplant for multiple myeloma

  2. An autologous stem cell transplant less than or equal to (<=) 12 weeks beforeapheresis

  • Known active, or prior history of, central nervous system (CNS) involvement orexhibits clinical signs of meningeal involvement of multiple myeloma

Study Design

Total Participants: 123
Treatment Group(s): 1
Primary Treatment: LCAR-B38M CAR-T Cell
Phase: 2
Study Start date:
January 23, 2019
Estimated Completion Date:
October 20, 2025

Connect with a study center

  • Peking University Third Hospital

    Beijing, Beijing 100191
    China

    Site Not Available

  • Peking University Third Hospital

    Beijing 1816670, Beijing Municipality 2038349 100191
    China

    Site Not Available

  • Fujian Medical University Union hospital

    Fuzhou, Fujian 350001
    China

    Site Not Available

  • Fujian Medical University Union hospital

    Fuzhou 1810821, Fujian 1811017 350001
    China

    Site Not Available

  • Sun Yat -Sen University Cancer Center

    Guandong, Guangzhou 510060
    China

    Site Not Available

  • Sun Yat -Sen University Cancer Center

    Guandong 9802037, Guangzhou 510060
    China

    Site Not Available

  • Jiangsu Province Hospital

    Nanjing, Jiangsu 210029
    China

    Site Not Available

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu 210008
    China

    Site Not Available

  • Jiangsu Province Hospital

    Nanjing 1799962, Jiangsu 1806260 210029
    China

    Site Not Available

  • Nanjing Drum Tower Hospital

    Nanjing 1799962, Jiangsu 1806260 210008
    China

    Site Not Available

  • Ruijin Hospital, Shanghai Jiao Tong University

    Shanghai, Shanghai 200025
    China

    Site Not Available

  • Shanghai Changzheng Hospital

    Shanghai, Shanghai 200003
    China

    Site Not Available

  • Shanghai Fourth People Hospital

    Shanghai, Shanghai 200434
    China

    Site Not Available

  • Ruijin Hospital, Shanghai Jiao Tong University

    Shanghai 1796236, Shanghai Municipality 1796231 200025
    China

    Site Not Available

  • Shanghai Changzheng Hospital

    Shanghai 1796236, Shanghai Municipality 1796231 200003
    China

    Site Not Available

  • Shanghai Fourth People Hospital

    Shanghai 1796236, Shanghai Municipality 1796231 200434
    China

    Site Not Available

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shanxi 710004
    China

    Site Not Available

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi’an 11474004, Shanxi 1795912 710004
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Chengdu 1815286, Sichuan 1794299 610041
    China

    Site Not Available

  • The First Affiliated Hospital, Medical School of Zhejiang University

    Hangzhou, Zhejiang 310003
    China

    Site Not Available

  • The First Affiliated Hospital, Medical School of Zhejiang University

    Hangzhou 1808926, Zhejiang 1784764 310003
    China

    Site Not Available

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