Relapsed/Refractory Myeloma
Conditions
Brief summary
Evaluation of the safety and efficacy of BCMA nanobody CAR-T cells in relapsed/refractory myeloma
Detailed description
There are no effective regimens for relapsed/refractory myeloma. BCMA express extensively in mature B cells and plasma cells. Myeloma cells express BCMA universally. BCMA signal pathway can induce plasma cell proliferation and survival, down-regulation of BCMA could control the progression of myeloma. The BCMA CAR used in this study consists of BCMA nanobody, CD8 hinge, transmembrane region and 4-1bb co-stimulation domain.
Interventions
DRUGBCMA nanobody CAR-T cells
step 1: Collect 50-100ml of peripheral blood for culture of BCMA nanobody CAR- T cells. step 2. After 72 hours, pretreated with FC regimen, details as follow Cyclophosphamide 600-800mg/m2 for 2 days Fludarabine 25-30mg/m2 for 3 days. step 3: After another 48 hours transfusion the cells back to the patients the numbers of infused CAR T cells are 5x106 /kg for the first 3 patients, 1.5x107 /kg for the second 3 patients and 4.5x107 /kg for the third 3 patients. After finishing this, another 6 patients will be enrolled for observation of efficacy.
Sponsors
The Pregene (ShenZhen) Biotechnology Company, Ltd.
Henan Cancer Hospital
Study design
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 18 and ≤70 years old and the expected lifetime \>3 months * Active myeloma according to IMWG criteria, and BCMA positive by immunohistochemistry or flow cytometry * No effective treatment option available * ECOG score 0-2 * Sufficient heart, liver, kidney function (heart: no heart disease or coronary heart disease, patient heart function NYHA grade 1-2; liver: TBIL ≤ 3ULN, AST ≤ 2.5ULN, ALT ≤ 2.5ULN; kidney: Cr≤ 1.25ULN); * smoothly peripheral superficial veins * No other serious diseases that conflict with this protocol (eg, autoimmune diseases, immunodeficiency, organ transplantation) * No history of other malignancies * Women of childbearing age must be negative for blood pregnancy test within 7 days and must take appropriated contraceptive measures during and 3 months after the study * The patient himself agrees to participate in this clinical study and signed the informed consent
Exclusion criteria
* Severe infectious 4 weeks before enrollment * Active hepatitis B or C viral hepatitis, HIV, * Severe autoimmune disease or immunodeficiency disease * Severe allergies * Severe mental disorder * Patients who used high-dose glucocorticoids within 1 week * Participation in other clinical studies in the past 3 months or having been treated with other gene products
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| occurrence of study related adverse events | 4 weeks | safety of CAR-T cells |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment response rate | 3 months and 6 months | response rate according to IMWG criteria |
| copy number of CAR-T cells | one year | copy number of CAR-T cells |
Countries
China
Contacts
Primary ContactYongping Song, M.D
Backup ContactQuanli Gao, M.D
Outcome results
None listed