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LCAR-B4822M-02 Cells in Treating Relapsed/Refractory (R/R) Multiple Myeloma

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: NCT03674463
Recruitment Status : Active, not recruiting
First Posted : September 17, 2018
Last Update Posted : December 14, 2018
Sponsor:
Collaborator:
Nanjing Legend Biotech Co.
Information provided by (Responsible Party):
Second Affiliated Hospital of Xi'an Jiaotong University

Study Description
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Brief Summary:
This is a single arm, open-label, phase 1 study, to determine the safety and efficacy of LCAR-B4822M 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 Drug: LCAR-B4822M CAR-T Cell Immunotherapy Phase 1

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, there is an unmet clinical needs for these patients. B-cell maturation antigen (BCMA) is a protein expressed by normal plasma cells and the malignant plasma cells of multiple myeloma, and it was supposed to be a promising target for r/r MM.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: LCAR-B4822M-02 Cells in Treating Relapsed/Refractory (R/R) Multiple Myeloma
Actual Study Start Date : July 26, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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Arm Intervention/treatment
Experimental: LCAR-B4822M treatment group
r/r multiple myeloma patients will be treated with LCAR-B4822M CAR-T cells with a escalation approach, 0.5x10^6- 2.0x10^6 CAR-T cells/kg.
 Drug: LCAR-B4822M CAR-T Cell Immunotherapy
Patients will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of CAR-T cells. After a pre-treatment lymphodepletion therapy, patients will receive the LCAR-B4822M CAR-T Cell Immunotherapy by intravenous injection.


Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of treatment related adverse events [ Time Frame: Day 1-30 days after injection ]
    Assessed by CTCAE v4.0


Secondary Outcome Measures :
  1. Anti-myeloma responses to LCAR-B4822M cell treatment [ Time Frame: Day 1-36 months after injection ]
    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 injection ]
    multiple myeloma cells in bone marrow


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 73 Years   (Adult, Older Adult)
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674463


Locations
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China, Shaanxi
Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710000
Sponsors and Collaborators
Second Affiliated Hospital of Xi'an Jiaotong University
Nanjing Legend Biotech Co.
Investigators
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Principal Investigator: Wan-Hong Zhao, MD, PhD Second Affiliated Hospital of Xi'an Jiaotong University
More Information
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Responsible Party: Second Affiliated Hospital of Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT03674463    
Other Study ID Numbers: LCAR-B4822M
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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