CAR-T cell therapy for relapsed or refractory multiple myeloma in Chinese patients

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

This study is testing a new CAR-T cell therapy to see if it can help Chinese patients with multiple myeloma who haven't responded to other treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nanjing Legend Biotech Co. (Industry-sponsored)
• Drugs / interventions: CAR-T, chimeric antigen receptor, prednisone
• Locations: 11 sites (Beijing, Beijing and 10 other locations)
• Trial ID: NCT03758417 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of LCAR-B38M chimeric antigen receptor T (CAR-T) cells in treating Chinese participants with relapsed or refractory multiple myeloma. Eligible patients must have a documented diagnosis of multiple myeloma, measurable disease, and have undergone at least three prior lines of treatment. The study aims to determine how well this CAR-T therapy works in patients who have not responded to previous treatments. Participants will be monitored for their response to the therapy and any potential side effects.

Who should consider this trial

Good fit: Ideal candidates are Chinese patients with relapsed or refractory multiple myeloma who have received at least three prior lines of treatment.

Not a fit: Patients who have not been diagnosed with multiple myeloma or those who have not received the required prior treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with difficult-to-treat multiple myeloma.

How similar studies have performed: Other studies involving CAR-T therapies for multiple myeloma have shown promising results, indicating potential success for this approach.

Eligibility 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

Where this trial is running

Beijing, Beijing and 10 other locations

• Peking University Third Hospital — Beijing, Beijing, China (Recruiting)
• Fujian Medical University Union hospital — Fuzhou, Fujian, China (Recruiting)
• Sun Yat -Sen University Cancer Center — Guandong, Guangzhou, China (Recruiting)
• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
• Jiangsu Province Hospital — Nanjing, Jiangsu, China (Recruiting)
• Shanghai Changzheng Hospital — Shanghai, Shanghai, China (Recruiting)
• Ruijin Hospital, Shanghai Jiao Tong University — Shanghai, Shanghai, China (Recruiting)
• Shanghai Fourth People Hospital — Shanghai, Shanghai, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shanxi, China (Recruiting)
• West China Hospital, Sichuan University — Chengdu, Sichuan, China (Recruiting)
• The First Affiliated Hospital, Medical School of Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Xiaohu Fan

Conditions Multiple Myeloma