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

Primary Purpose

Refractory or Relapsed Multiple Myeloma

Status
Active
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
LCAR-B38M CAR-T cell injection
Sponsored by
Nanjing Legend Biotech Co.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory or Relapsed Multiple Myeloma focused on measuring multiple myeloma, BCMA, CAR-T

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    LCAR-B38M treatment group

    Arm Description

    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).

    Outcomes

    Primary Outcome Measures

    Occurrence of treatment related adverse events as assessed by CTCAE v4.0
    >= Grade 1 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment

    Secondary Outcome Measures

    Anti-myeloma responses to LCAR-B38M cell treatment
    by measuring the changes of aberrant immunoglobulin in serum
    Anti-myeloma responses to LCAR-B38M cell treatment
    multiple myeloma cells in bone marrow.

    Full Information

    First Posted
    March 7, 2017
    Last Updated
    June 8, 2023
    Sponsor
    Nanjing Legend Biotech Co.
    Collaborators
    Second Affiliated Hospital of Xi'an Jiaotong University, Ruijin Hospital, Jiangsu Provincial People's Hospital, Shanghai Changzheng Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03090659
    Brief Title
    LCAR-B38M Cells in Treating Relapsed/Refractory (R/R) Multiple Myeloma
    Acronym
    LEGEND-2
    Official Title
    A Clinical Study of Legend Biotech BCMA-chimeric Antigen Receptor Technology in Treating Relapsed/Refractory (R/R) Multiple Myeloma Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Active, not recruiting
    Study Start Date
    October 2, 2015 (Actual)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Nanjing Legend Biotech Co.
    Collaborators
    Second Affiliated Hospital of Xi'an Jiaotong University, Ruijin Hospital, Jiangsu Provincial People's Hospital, Shanghai Changzheng Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Refractory or Relapsed Multiple Myeloma
    Keywords
    multiple myeloma, BCMA, CAR-T

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    LCAR-B38M treatment group
    Arm Type
    Experimental
    Arm Description
    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).
    Intervention Type
    Biological
    Intervention Name(s)
    LCAR-B38M CAR-T cell injection
    Primary Outcome Measure Information:
    Title
    Occurrence of treatment related adverse events as assessed by CTCAE v4.0
    Description
    >= Grade 1 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment
    Time Frame
    Day 1-30 days after injection
    Secondary Outcome Measure Information:
    Title
    Anti-myeloma responses to LCAR-B38M cell treatment
    Description
    by measuring the changes of aberrant immunoglobulin in serum
    Time Frame
    Day 1-36 months after three split doses
    Title
    Anti-myeloma responses to LCAR-B38M cell treatment
    Description
    multiple myeloma cells in bone marrow.
    Time Frame
    Day 1-36 months after three split doses

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    35794616
    Citation
    Zhao WH, Wang BY, Chen LJ, Fu WJ, Xu J, Liu J, Jin SW, Chen YX, Cao XM, Yang Y, Zhang YL, Wang FX, Zhang PY, Lei B, Gu LF, Wang JL, Zhang H, Bai J, Xu Y, Zhu H, Du J, Jiang H, Fan XH, Li JY, Hou J, Chen Z, Zhang WG, Mi JQ, Chen SJ, He AL. Four-year follow-up of LCAR-B38M in relapsed or refractory multiple myeloma: a phase 1, single-arm, open-label, multicenter study in China (LEGEND-2). J Hematol Oncol. 2022 Jul 6;15(1):86. doi: 10.1186/s13045-022-01301-8.
    Results Reference
    derived
    PubMed Identifier
    30572922
    Citation
    Zhao WH, Liu J, Wang BY, Chen YX, Cao XM, Yang Y, Zhang YL, Wang FX, Zhang PY, Lei B, Gu LF, Wang JL, Yang N, Zhang R, Zhang H, Shen Y, Bai J, Xu Y, Wang XG, Zhang RL, Wei LL, Li ZF, Li ZZ, Geng Y, He Q, Zhuang QC, Fan XH, He AL, Zhang WG. A phase 1, open-label study of LCAR-B38M, a chimeric antigen receptor T cell therapy directed against B cell maturation antigen, in patients with relapsed or refractory multiple myeloma. J Hematol Oncol. 2018 Dec 20;11(1):141. doi: 10.1186/s13045-018-0681-6.
    Results Reference
    derived

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

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