Multiple Myeloma
Conditions
Brief summary
The purpose of this study is to infusion BCMA CAR-T cells to the patients with relapsed and refractory multiple myeloma(MM), to assess the safety and feasibility of this strategy. The CAR enables the T cell to recognize and kill the MM cells through the recognition of BCMA, a protein expressed of the surface of the malignant plasma cells in MM patients.
Interventions
DRUGFludarabine
25-30mg/m2/day IV for 3 days
DRUGCyclophosphamide
cyclophosphamide 0.6-0.8g/m2/day IV for 2 days
BIOLOGICALBCMA CAR-T
BCMA CAR-T cells will be administered after completion of the chemotherapy.
Sponsors
The Pregene (ShenZhen) Biotechnology Company, Ltd.
Henan Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 1\. 18 years to 70 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 0-2; * 5\. Cardiac function: 1-2 levels; Liver: TBIL≤3ULN，AST ≤2.5ULN，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; previously treatment with any gene therapy products;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | 1 year | number of participants with adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Persistence of the BCMA CAR+ T cells | 1 year | determine duration of in vivo survival of BCMA CAR-T cells |
| anti-tumor responses of BCMA CAR-T cells | 1 year | — |
Countries
China
Contacts
Primary ContactYongping Song
Outcome results
None listed