Multiple Myeloma
Conditions
Brief summary
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.
Interventions
BIOLOGICALBCMA CAR-NK 92 cells
The subject will be observed for any side effects during this time and all the adverse events will be recorded.
Sponsors
Asclepius Technology Company Group (Suzhou) Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of treatment related adverse events as assessed by CTCAE v4.03 | 1 year | Defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment. |
Countries
China
Contacts
Primary ContactGuangfu Li
Backup ContactXianfeng Feng
Outcome results
None listed