LCAR-B4822M-02 Cells in Treating Relapsed/Refractory (R/R) Multiple Myeloma
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ClinicalTrials.gov Identifier: NCT03674463 |
Recruitment Status : Unknown
Verified September 2018 by Second Affiliated Hospital of Xi'an Jiaotong University.
Recruitment status was: Active, not recruiting
First Posted : September 17, 2018
Last Update Posted : December 14, 2018
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Condition or disease | Intervention/treatment | Phase |
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Refractory or Relapsed Multiple Myeloma | Drug: LCAR-B4822M CAR-T Cell Immunotherapy | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | LCAR-B4822M-02 Cells in Treating Relapsed/Refractory (R/R) Multiple Myeloma |
Actual Study Start Date : | July 26, 2018 |
Estimated Primary Completion Date : | December 31, 2020 |
Estimated Study Completion Date : | December 31, 2020 |

Arm | Intervention/treatment |
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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.
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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. |
- Occurrence of treatment related adverse events [ Time Frame: Day 1-30 days after injection ]Assessed by CTCAE v4.0
- 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

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Ages Eligible for Study: | 18 Years to 73 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674463
China, Shaanxi | |
Second Affiliated Hospital of Xi'an Jiaotong University | |
Xi'an, Shaanxi, China, 710000 |
Principal Investigator: | Wan-Hong Zhao, MD, PhD | Second Affiliated Hospital of Xi'an Jiaotong University |
Responsible Party: | Second Affiliated Hospital of Xi'an Jiaotong University |
ClinicalTrials.gov Identifier: | NCT03674463 |
Other Study ID Numbers: |
LCAR-B4822M |
First Posted: | September 17, 2018 Key Record Dates |
Last Update Posted: | December 14, 2018 |
Last Verified: | September 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |