Clinical trial · Interventional
Clinical Research of Adoptive BCMA CAR-NK Cells on Relapse/Refractory MM
NCT03940833CI-TRIAL-00038497unknownPhase 1 / Phase 2ClinicalTrials.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)
The purpose of this study is to infuse BCMA CAR-NK 92 cells to the patients with relapsed and refractory multiple myeloma (MM), to assess the safety and feasibility of this strategy. The CAR enables the NK-92 cells to recognize and kill the MM cells by targeting of BCMA, a protein expressed of the surface of the malignant plasma cells in MM patients.
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 |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BCMA CAR-NK 92 cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- anti-tumor response of BCMA CAR-NK-92
- description
- Patients with relapsed and refractory MM of BCMA expression will be treated with BCMA CAR-NK 92 cells.
- interventionNames
- Biological: BCMA CAR-NK 92 cells
Primary outcomes (1)
- measure
- Occurrence of treatment related adverse events as assessed by CTCAE v4.03
- timeFrame
- 1 year
- description
- Defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. 18 years to 80 years, expected survival \> 3 months 2. Confirmed diagnosis of active MM as defined by IMWG. BCMA expression of the malignant cells must be detected by immunohistochemistry or by flow cytometry 3. BCMA-expressing B cell malignancy must be assured and must be relapsed or refractory disease 4. ECOG performance status of 0 - 1 5. Cardiac function: 1 - 2 levels; Liver: TBIL ≤ 3ULN，AST ≤ 2.5 ULN，ALT ≤ 2.5ULN; kidney: Cr ≤ 1.25ULN 6. No serious allergic constitution 7. No other serous diseases that conflicts with the clinical program 8. No other cancer history 9. Female participants of reproductive potential must have a negative serum pregnancy test 10. Subjects must have signed written, informed consent Exclusion Criteria: 1. Pregnant or lactating women 2. Uncontrolled active infection, HIV infection, syphilis serology reaction positive 3. Active hepatitis B or hepatitis C infection 4. Recent or current use of glucocorticoid or other immunosuppressor 5. Serious mental disorder 6. With severe cardiac, liver, renal insufficiency, diabetes and other diseases 7. Participate in other clinical research in the past three months 8. Previously treatment with any gene therapy products
References
Publications (1)
- DERIVEDNg YY, Du Z, Zhang X, Chng WJ, Wang S. CXCR4 and anti-BCMA CAR co-modified natural killer cells suppress multiple myeloma progression in a xenograft mouse model. Cancer Gene Ther. 2022 May;29(5):475-483. doi: 10.1038/s41417-021-00365-x. Epub 2021 Sep 1. PMID 34471234