LCAR-B38M Cells in Treating Relapsed/Refractory (R/R) Multiple Myeloma
- Conditions
- Refractory or Relapsed Multiple Myeloma
- Interventions
- Biological: LCAR-B38M CAR-T cell injection
- Registration Number
- NCT03090659
- Lead Sponsor
- Nanjing Legend Biotech Co.
- Brief Summary
This is a single arm, open-label, multi-center, phase 1/2 study, to determine the safety and efficacy of LCAR-B38M 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 and die, an clear unmet clinical needs. As early as mid-2014, the investigators have started to develop a series of proprietary CAR-T products to target B cell maturation antigen (BCMA), a cell surface molecule which the investigator believes to be a desirable target antigen for multiple myeloma. All pre-clinical data and CMC data for LCAR-B38M CAR-T cell technology has been established by mid-2015 and a phase I proof-of-concept clinical trial has been planned since then.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LCAR-B38M treatment group LCAR-B38M CAR-T cell injection r/r multiple myeloma patients be treated with a split doses of LCAR-B38M cells. Total dose of 0.5-5 millions /kg cells will be administered at day 0, day 2 and day 6 by split dose (20%, 30% and 50% respectively).
- Primary Outcome Measures
Name Time Method Occurrence of treatment related adverse events as assessed by CTCAE v4.0 Day 1-30 days after injection \>= Grade 1 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment
- Secondary Outcome Measures
Name Time Method Anti-myeloma responses to LCAR-B38M cell treatment Day 1-36 months after three split doses multiple myeloma cells in bone marrow.