Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE September 12, 2018
First Posted Date  ICMJE September 17, 2018
Last Update Posted Date December 14, 2018
Actual Study Start Date  ICMJE July 26, 2018
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2018)
Occurrence of treatment related adverse events [ Time Frame: Day 1-30 days after injection ]
Assessed by CTCAE v4.0
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2018)
  • 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
  • Anti-myeloma responses to LCAR-B38M cell treatment [ Time Frame: Day 1-36 months after injection ]
    multiple myeloma cells in bone marrow
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE LCAR-B4822M-02 Cells in Treating Relapsed/Refractory (R/R) Multiple Myeloma
Official Title  ICMJE LCAR-B4822M-02 Cells in Treating Relapsed/Refractory (R/R) Multiple Myeloma
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Refractory or Relapsed Multiple Myeloma
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Drug: LCAR-B4822M CAR-T Cell Immunotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 12, 2018)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 73 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03674463
Other Study ID Numbers  ICMJE LCAR-B4822M
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Second Affiliated Hospital of Xi'an Jiaotong University
Study Sponsor  ICMJE Second Affiliated Hospital of Xi'an Jiaotong University
Collaborators  ICMJE Nanjing Legend Biotech Co.
Investigators  ICMJE
Principal Investigator: Wan-Hong Zhao, MD, PhD Second Affiliated Hospital of Xi'an Jiaotong University
PRS Account Second Affiliated Hospital of Xi'an Jiaotong University
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP