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
NCT ID: NCT03758417
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
123 participants
INTERVENTIONAL
2019-01-23
2025-10-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LCAR-B38M Chimeric Antigen Receptor T Cell
Participants will receive LCAR-B38M CAR-T cells as a single infusion which consists of autologous T lymphocytes transduced with LCAR-B38M, a lentiviral vector to express a chimeric antigen receptor targeting the human B cell maturation antigen (anti-BCMA CAR).
In addition, participants will enroll in additional cohort to further characterize the safety profile and accumulate efficacy data of LCAR-B38M CAR-T cells.
LCAR-B38M CAR-T Cell
Participants will receive LCAR-B38M CAR-T cells as a single infusion which consists of autologous T lymphocytes transduced with LCAR-B38M, a lentiviral vector to express a chimeric antigen receptor targeting the human B cell maturation antigen (anti-BCMA CAR).
Interventions
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LCAR-B38M CAR-T Cell
Participants will receive LCAR-B38M CAR-T cells as a single infusion which consists of autologous T lymphocytes transduced with LCAR-B38M, a lentiviral vector to express a chimeric antigen receptor targeting the human B cell maturation antigen (anti-BCMA CAR).
Other Intervention Names
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Eligibility Criteria
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Inclusion 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, unless progressive disease (PD) was documented by IMWG criteria as the best response to the regimen
* Received a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD)
* Participant must have documented evidence of progressive disease based on investigator's determination of response consistent with IMWG criteria on or within 12 months of their last regimen. Non-responsive disease is defined as either failure to achieve minimal response or development of progressive disease (PD) while on therapy. Also, participants with documented evidence of PD disease (as above) within the previous 6 months and who are refractory or non-responsive to their most recent line of treatment afterwards are eligible
* Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1
Exclusion Criteria
* Any therapy that is targeted to B-cell maturation antigen (BCMA)
* The following cardiac conditions: a) New York Heart Association (NYHA) stage III or IV congestive heart failure b) Myocardial infarction or coronary artery bypass graft (CABG) 6 months prior to enrollment c) History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration d) History of severe non-ischemic cardiomyopathy e) Impaired cardiac function (left ventricular ejection fraction \[LVEF\] less than \[\<\]45%) as assessed by echocardiogram or multiple-gated acquisition (MUGA) scan (performed less than or equal to (\<=) 8 weeks of apheresis)
* Have received a cumulative dose of corticosteroids equivalent to greater than or equal 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 disease present 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 to Grade 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 before apheresis
* Known active, or prior history of, central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Nanjing Legend Biotech Co.
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research&Development,LLC Clinical Trail
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Peking University Third Hospital
Beijing, Beijing Municipality, China
Fujian Medical University Union hospital
Fuzhou, Fujian, China
Sun Yat -Sen University Cancer Center
Guandong, Guangzhou, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
Ruijin Hospital, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
Shanghai Fourth People Hospital
Shanghai, Shanghai Municipality, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
The First Affiliated Hospital, Medical School of Zhejiang University
Hangzhou, Zhejiang, China
Countries
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References
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Mi JQ, Zhao W, Jing H, Fu W, Hu J, Chen L, Zhang Y, Yao D, Chen D, Schecter JM, Yang F, Tian X, Sun H, Zhuang SH, Ren J, Fan X, Jin J, Niu T, Chen SJ. Phase II, Open-Label Study of Ciltacabtagene Autoleucel, an Anti-B-Cell Maturation Antigen Chimeric Antigen Receptor-T-Cell Therapy, in Chinese Patients With Relapsed/Refractory Multiple Myeloma (CARTIFAN-1). J Clin Oncol. 2023 Feb 20;41(6):1275-1284. doi: 10.1200/JCO.22.00690. Epub 2022 Oct 21.
Other Identifiers
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68284528MMY2002
Identifier Type: OTHER
Identifier Source: secondary_id
CR108494
Identifier Type: -
Identifier Source: org_study_id