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 (CARTIFAN-1)

December 12, 2025 updated by: Nanjing Legend Biotech Co.

A Phase 2, Open-Label Study of LCAR-B38M CAR-T Cells, a Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against BCMA in Chinese Subjects With Relapsed or Refractory Multiple Myeloma

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
123

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100191
        • Peking University Third Hospital
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Medical University Union Hospital
    • Guangzhou
      • Guandong, Guangzhou, China, 510060
        • Sun Yat -Sen University Cancer Center
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Nanjing Drum Tower Hospital
      • Nanjing, Jiangsu, China, 210029
        • Jiangsu Province Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200003
        • Shanghai Changzheng Hospital
      • Shanghai, Shanghai Municipality, China, 200025
        • Ruijin Hospital, Shanghai Jiao Tong University
      • Shanghai, Shanghai Municipality, China, 200434
        • Shanghai Fourth People Hospital
    • Shanxi
      • Xi’an, Shanxi, China, 710004
        • The Second Affiliated Hospital of Xi'an Jiaotong University
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital, Sichuan University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • The First Affiliated Hospital, Medical School of Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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:

    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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Biological: 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 Names:
  • Ciltacabtagene autoleucel

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
Time Frame: Minimum 2 years after LCAR-B38M chimeric antigen receptor T (CAR-T) infusion (Day 1)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events
Time Frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Chimeric Antigen Receptor T (CAR-T) Positive Cell Concentration
Time Frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Venous blood samples will be collected for measurement of CAR-T positive cellular concentration.
Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Transgene Levels of LCAR-B38M CAR-T Cells
Time Frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Transgene Levels of LCAR-B38M CAR-T Cells using sensitive assay methods will be assessed.
Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Systemic Cytokine Concentrations
Time Frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Serum cytokine concentrations such as Interleukin [IL]-6, IL-15, IL-10 will be measured for biomarker assessment.
Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Number of Participants With Anti- LCAR-B38M CAR-T Cell Antibodies
Time Frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Number of participants with anti- LCAR-B38M CAR-T cell antibodies will be evaluated.
Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Percentage of Participants with Very Good Partial Response (VGPR) or Better Rate
Time Frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
The VGPR or better rate, defined as the percentage of participants achieving VGPR and complete response (CR) (including stringent complete response [sCR]) according to IMWG criteria during or after the study treatment. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or greater than or equal to (>=) 90 percent (%) reduction in serum Mprotein plus urine M-protein less than (<) 100 milligram (mg)/24 hours, CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells (PCs) in bone marrow. sCR: CR plus normal free light chain (FLC) ratio, and absence of clonal PCs by immunohistochemistry (IHC), immunofluorescence for 2 to 4 color flow cytometry.
Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Percentage of Participants with Complete Response (CR)
Time Frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Complete response is based on serum M-Protein and bone marrow assessments as per IMWG criteria.
Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Percentage of Participants with Negative Minimal Residual Disease (MRD)
Time Frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Minimal residual disease negative rate is defined as the percentage of participants who achieve MRD negative status by the respective time point. MRD will be assessed by bone marrow 8-colored flow cytometry.
Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Percentage of Participants who Achieve Clinical Benefit
Time Frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Clinical Benefit Rate is defined as the percentage of participants who achieve ORR (sCR + CR + VGPR + PR) and minimal response (MR) as per IMWG criteria.
Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Duration of Response (DOR)
Time Frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Duration of response (DOR) will be calculated among responders (with a PR or better response) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria or death due to any cause, whichever occurs first.
Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Time to Response (TTR)
Time Frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Time to response (TTR) is defined as the time between date of the initial infusion of LCAR-B38M CAR-T cells and the first efficacy evaluation that the participant has met all criteria for PR or better.
Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Progression-Free Survival (PFS)
Time Frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
PFS defined as time from date of initial infusion of LCAR-B38M CAR-T cells to date of first documented disease progression, defined in the IMWG criteria, or death due to any cause, whichever occurs first.
Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Overall survival (OS)
Time Frame: Mnimum 2 years after LCAR-B38M CART infusion (Day 1)
Overall survival (OS) is measured from the date of infusion of the LCAR-B38M CAR-T cells to the date of the participant's death.
Mnimum 2 years after LCAR-B38M CART infusion (Day 1)
Levels of CAR-T cell Activation Markers
Time Frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Levels of CAR-T cell Activation Markers like CD4+, CD8+, and CD25+ will be assessed. An evaluation of cell populations may be performed by flow cytometry.
Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Levels of LCAR-B38M CAR-T cell Expansion (proliferation)
Time Frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Levels of LCAR-B38M CAR-T cell expansion (proliferation) will be reported.
Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Levels of LCAR-B38M CAR-T Persistence
Time Frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Levels of LCAR-B38M CAR-T persistence will be evaluated via monitoring CAR-T positive cell counts and CART transgene levels.
Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Percentage of Participants with Stringent Complete Response (sCR)
Time Frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Stringent Complete Response (sCR) is based on serum M-Protein and bone marrow assessments as per IMWG criteria for complete response(CR) plus normal free light chain (FLC) ratio, and absence of clonal PCs by immunohistochemistry(IHC), or 2 to 4 color flow cytometry.
Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Circulating Soluble B-Cell Maturation Antigen (sBCMA) Levels
Time Frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Blood samples will be collected for measurement of sBCMA level.
Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Percent Reduction in BCMA Expression Cells
Time Frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
Percent reduction in BCMA Expression Cells will be measured.
Minimum 2 years after LCAR-B38M CART infusion (Day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanjing Legend Biotech Co.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Janssen Research & Development, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research&Development,LLC Clinical Trail, Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 23, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 10, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108494
  • 68284528MMY2002 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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