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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03758417
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Nanjing Legend Biotech Co.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Janssen Research&Development,LLC Clinical Trail
Principal Investigator Affiliation Janssen Research & Development, LLC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Arms & Interventions

Arms

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.

Interventions

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).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Peking University Third Hospital, Beijing, Beijing, China

Status

Recruiting

Address

Peking University Third Hospital

Beijing, Beijing, 100191

Fujian Medical University Union hospital, Fuzhou, Fujian, China

Status

Recruiting

Address

Fujian Medical University Union hospital

Fuzhou, Fujian, 350001

Jiangsu Province Hospital, Nanjing, Jiangsu, China

Status

Recruiting

Address

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029

Shanghai Changzheng Hospital, Shanghai, Shanghai, China

Status

Recruiting

Address

Shanghai Changzheng Hospital

Shanghai, Shanghai, 200003

Shanghai, Shanghai, China

Status

Recruiting

Address

Ruijin Hospital, Shanghai Jiao Tong University

Shanghai, Shanghai, 200025

Xi'an, Shanxi, China

Status

Recruiting

Address

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shanxi, 710004

West China Hospital, Sichuan University, Chengdu, Sichuan, China

Status

Recruiting

Address

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041

Hangzhou, Zhejiang, China

Status

Recruiting

Address

The First Affiliated Hospital, Medical School of Zhejiang University

Hangzhou, Zhejiang, 310003