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LCAR-B38M-02 Cells in Treating Relapsed/Refractory (R/R) Multiple Myeloma (LEGEND-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03090659
Recruitment Status : Enrolling by invitation
First Posted : March 27, 2017
Last Update Posted : July 7, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a single arm, open-label, multi-center, phase 1/2 study, to determine the safety and efficacy of LCAR-B38M CAR-T cells in treating patients diagnosed with refractory/relapsed multiple myeloma (r/r MM).

Condition or disease Intervention/treatment Phase
Refractory or Relapsed Multiple Myeloma Biological: LCAR-B38M CAR-T cell injection Phase 1 Phase 2

Detailed Description:
Multiple myeloma (MM) is a usually incurable malignancy of plasma cells. Current therapies for multiple myeloma often cause remissions, but nearly all patients eventually relapse and die, an clear unmet clinical needs. As early as mid-2014, the investigators have started to develop a series of proprietary CAR-T products to target B cell maturation antigen (BCMA), a cell surface molecule which the investigator believes to be a desirable target antigen for multiple myeloma. All pre-clinical data and CMC data for LCAR-B38M CAR-T cell technology has been established by mid-2015 and a phase I proof-of-concept clinical trial has been planned since then.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Study of Legend Biotech BCMA-chimeric Antigen Receptor Technology in Treating Relapsed/Refractory (R/R) Multiple Myeloma Patients
Actual Study Start Date : October 2, 2015
Estimated Primary Completion Date : December 1, 2017
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: LCAR-B38M treatment group
r/r multiple myeloma patients be treated with a split doses of LCAR-B38M cells. Total dose of 0.5-5 millions /kg cells will be administered at day 0, day 2 and day 6 by split dose (20%, 30% and 50% respectively).
Biological: LCAR-B38M CAR-T cell injection


Outcome Measures

Primary Outcome Measures :
  1. Occurrence of treatment related adverse events as assessed by CTCAE v4.0 [ Time Frame: Day 1-30 days after injection ]
    >= Grade 1 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment


Secondary Outcome Measures :
  1. Anti-myeloma responses to LCAR-B38M cell treatment [ Time Frame: Day 1-36 months after three split doses ]
    by measuring the changes of aberrant immunoglobulin in serum

  2. Anti-myeloma responses to LCAR-B38M cell treatment [ Time Frame: Day 1-36 months after three split doses ]
    multiple myeloma cells in bone marrow.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have a confirmed prior diagnosis of active multiple myeloma as defined by the updated IMWG criteria.
  • Patients with refractory multiple myeloma. Clear BCMA expression must be detected on malignant plasma cells from either bone marrow or a plasmacytoma by flow cytometry or immunohistochemistry.
  • Refractory disease:1) At least 3 prior regimens, which must at least have contained bortezomi. or 2) other circumstances identified by clinical doctors.
  • Relapse criteria in NCCN clinical practice guidelines in Oncology: Multiple Myeloma (2016.V2)

Exclusion Criteria:

  • Women of child-bearing potential or who are pregnant or breastfeeding.
  • Have any active and uncontrolled infection: hepatitis B, hepatitis C, HIV, or other fatal viral and bacterial infection.
  • Systemic corticosteroid steroid therapy of greater than 5 mg/day of prednisone or equivalent dose of another corticosteroid are not allowed within 2 weeks prior to either the required leukapheresis or the initiation of the conditioning chemotherapy regimen.
  • Patients with any uncontrolled intercurrent illness or serious uncontrolled medical disorder.
  • Patients with CNS metastases or symptomatic CNS involvement (including cranial neuropathies or mass lesions and spinal cord compression).
  • History of allogeneic stem cell transplantation. Have active acute or chronic graft-versus-host-disease (GVHD), or require immunosuppressant medications for GVHD, within 6 months of enrollment.
  • Patients with active autoimmune skin diseases such as psoriasis or other active autoimmune diseases such as rheumatoid arthritis.
More Information

Responsible Party: Nanjing Legend Biotech Co.
ClinicalTrials.gov Identifier: NCT03090659     History of Changes
Other Study ID Numbers: LCAR-B38M-02
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: July 7, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nanjing Legend Biotech Co.:
multiple myeloma
BCMA
CAR-T

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases