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)

Legend Biotech

Status and phase: Terminated; Phase 2

Conditions: Multiple Myeloma

Treatments: Biological: LCAR-B38M CAR-T Cell

Study type: Interventional

Funder types: Industry

Identifiers

NCT03758417

CR108494

68284528MMY2002 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 123 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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123 participants in 1 patient group

LCAR-B38M Chimeric Antigen Receptor T Cell

Experimental group

Description:

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.

Treatment:

Biological: LCAR-B38M CAR-T Cell