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

NCT ID: NCT03674463

Last Updated: 2018-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-26

Study Completion Date

2020-12-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Refractory or Relapsed Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

LCAR-B4822M CAR-T Cell Immunotherapy

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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 diseaseļ¼š1) 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

73 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing Legend Biotech Co.

INDUSTRY

Sponsor Role collaborator

Second Affiliated Hospital of Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wan-Hong Zhao, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Xi'an Jiaotong University

Locations

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Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status

Countries

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China

Other Identifiers

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LCAR-B4822M

Identifier Type: -

Identifier Source: org_study_id