Back to resultsCAR-T Re-treatment for Refractory/Relapsed Multiple Myeloma
Primary Purpose
Multiple Myeloma, Multiple Myeloma in Relapse, Multiple Myeloma Progression
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CAR-T Re-treatment
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma
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.
- other conditions that excluded by clinicians.
Sites / Locations
- Second Affiliated Hospital of Xi'an Jiaotong University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CAR-T Re-treatment group
Arm Description
Patients will be treated with CAR-T cells targeting BCMA (Different epitope with the previous CAR-T cell treatment they had been used) with a escalation approach, 0.5x10^6- 2.0x10^6 CAR-T cells/kg.
Outcomes
Primary Outcome Measures
Occurrence of treatment related adverse events
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
by measuring the changes of aberrant immunoglobulin in serum
Anti-myeloma responses
multiple myeloma cells in bone marrow
Full Information
NCT ID
NCT03672253
First Posted
September 13, 2018
Last Updated
December 13, 2018
Sponsor
Second Affiliated Hospital of Xi'an Jiaotong University
Collaborators
Nanjing Legend Biotech Co.
1. Study Identification
Unique Protocol Identification Number
NCT03672253
Brief Title
CAR-T Re-treatment for Refractory/Relapsed Multiple Myeloma
Official Title
Study of CAR-T Cells Targeting BCMA for Previously CAR-T Treated Refractory/Relapsed Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 26, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Xi'an Jiaotong University
Collaborators
Nanjing Legend Biotech Co.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a single arm, open-label, single-center, phase 1 study, to determine the safety and efficacy of autologous reinfusion of CAR-T cells targeting BCMA in the treatment of refractory/relapsed multiple myeloma (r/r MM) who get recurrence and progression after previous CAR-T cell therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Multiple Myeloma in Relapse, Multiple Myeloma Progression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CAR-T Re-treatment group
Arm Type
Experimental
Arm Description
Patients will be treated with CAR-T cells targeting BCMA (Different epitope with the previous CAR-T cell treatment they had been used) with a escalation approach, 0.5x10^6- 2.0x10^6 CAR-T cells/kg.
Intervention Type
Drug
Intervention Name(s)
CAR-T Re-treatment
Other Intervention Name(s)
CAR-T Re-treatment for r/r MM targeting BCMA
Intervention Description
Patients will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) or use their mononuclear cells that preserved in the laboratory for the production of CAR-T cells. After a pre-treatment lymphodepletion therapy, patients will receive the re-treatment of CAR-T therapy by intravenous injection.
Primary Outcome Measure Information:
Title
Occurrence of treatment related adverse events
Description
assessed by CTCAE v4.0, >= 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
Description
by measuring the changes of aberrant immunoglobulin in serum
Time Frame
Day 1-60 months
Title
Anti-myeloma responses
Description
multiple myeloma cells in bone marrow
Time Frame
Day 1-60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 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.
other conditions that excluded by clinicians.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wan-Hong Zhao, MD, PhD
Organizational Affiliation
Second Affiliated Hospital of Xi'an Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Second Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
CAR-T Re-treatment for Refractory/Relapsed Multiple Myeloma
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