Clinical trial · Interventional
LCAR-B4822M-02 Cells in Treating Relapsed/Refractory (R/R) Multiple Myeloma
NCT03674463CI-TRIAL-00036138unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory or Relapsed Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LCAR-B4822M CAR-T Cell Immunotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LCAR-B4822M treatment group
- description
- 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.
- interventionNames
- Drug: LCAR-B4822M CAR-T Cell Immunotherapy
Primary outcomes (1)
- measure
- Occurrence of treatment related adverse events
- timeFrame
- Day 1-30 days after injection
- description
- Assessed by CTCAE v4.0
Secondary outcomes (2)
- measure
- Anti-myeloma responses to LCAR-B4822M cell treatment
- timeFrame
- Day 1-36 months after injection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 73 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.