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

NCT03758417 | Terminated Phase 2 FDA Drug

• 2 other identifiers: CR10849468284528MMY2002
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 11

Brief Summary

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

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  The ORR is defined as the percentage of participants who achieve at least a partial response (PR) or better according to international myeloma working group (IMWG) criteria.

  Minimum 2 years after LCAR-B38M chimeric antigen receptor T (CAR-T) infusion (Day 1)

Secondary Outcomes (19)

• Number of Participants With Adverse Events

  Minimum 2 years after LCAR-B38M CART infusion (Day 1)

• Chimeric Antigen Receptor T (CAR-T) Positive Cell Concentration

  Minimum 2 years after LCAR-B38M CART infusion (Day 1)

• Transgene Levels of LCAR-B38M CAR-T Cells

  Minimum 2 years after LCAR-B38M CART infusion (Day 1)

• Systemic Cytokine Concentrations

  Minimum 2 years after LCAR-B38M CART infusion (Day 1)

• Number of Participants With Anti- LCAR-B38M CAR-T Cell Antibodies

  Minimum 2 years after LCAR-B38M CART infusion (Day 1)

Study Arms (1)

LCAR-B38M Chimeric Antigen Receptor T Cell

EXPERIMENTAL

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.

Biological: LCAR-B38M CAR-T Cell

Interventions

LCAR-B38M CAR-T Cell BIOLOGICAL

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).

Also known as: Ciltacabtagene autoleucel

LCAR-B38M Chimeric Antigen Receptor T Cell

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented initial diagnosis of multiple myeloma according to International Myeloma Working 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, 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

You may not qualify if:

• Prior treatment with chimeric antigen receptor T (cells) CAR-T therapy directed at any target
• 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:
• Malignancy treated with curative intent and with no known active disease present for greater than or equal to (\>=) 2 years before enrollment; or
• 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:
• An allogeneic stem cell transplant for multiple myeloma
• 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

Sponsors & Collaborators

• Nanjing Legend Biotech Co.: lead
• Janssen Research & Development, LLC: collaborator

Study Sites (11)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Fujian Medical University Union hospital

Fuzhou, Fujian, 350001, China

Location

Sun Yat -Sen University Cancer Center

Guandong, Guangzhou, 510060, China

Location

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

Location

Ruijin Hospital, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200025, China

Location

Shanghai Fourth People Hospital

Shanghai, Shanghai Municipality, 200434, China

Location

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 710004, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

The First Affiliated Hospital, Medical School of Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

Related Publications (1)

• 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.

  PMID: 36269898 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Janssen Research&Development,LLC Clinical Trail

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: November 29, 2018
• Study Start: January 23, 2019
• Primary Completion: July 10, 2025
• Study Completion: October 20, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

CN (11)