Multiple Myeloma, Multiple Myeloma in Relapse, Multiple Myeloma Progression
Conditions
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.
Interventions
DRUGCAR-T Re-treatment
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.
Sponsors
Nanjing Legend Biotech Co.
Second Affiliated Hospital of Xi'an Jiaotong University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients must have a confirmed prior diagnosis of active multiple myeloma as defined by the updated IMWG criteria. 2. 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. 3. Refractory disease：1) At least 3 prior regimens, which must at least have contained bortezomi. or 2) other circumstances identified by clinical doctors. 4. Relapse criteria in NCCN clinical practice guidelines in Oncology: Multiple Myeloma (2016.V2).
Exclusion criteria
1. Women of child-bearing potential or who are pregnant or breastfeeding. 2. Have any active and uncontrolled infection: hepatitis B, hepatitis C, HIV, or other fatal viral and bacterial infection. 3. 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. 4. Patients with any uncontrolled intercurrent illness or serious uncontrolled medical disorder. 5. Patients with CNS metastases or symptomatic CNS involvement (including cranial neuropathies or mass lesions and spinal cord compression). 6. 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. 7. Patients with active autoimmune skin diseases such as psoriasis or other active autoimmune diseases such as rheumatoid arthritis. 8. other conditions that excluded by clinicians.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of treatment related adverse events | Day 1-30 days after injection | 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
| Measure | Time frame | Description |
|---|---|---|
| Anti-myeloma responses | Day 1-60 months | by measuring the changes of aberrant immunoglobulin in serum |
Countries
China
Outcome results
None listed