Relapsed/Refractory Myeloma Clinical Trial
Official title:
a Single-center, One Arm, Open Clinical Study of BCMA Nanobody CAR-T Cell in Refractory/Relapsed Myeloma
Evaluation of the safety and efficacy of BCMA nanobody CAR-T cells in relapsed/refractory myeloma
Status | Recruiting |
Enrollment | 15 |
Est. completion date | April 30, 2020 |
Est. primary completion date | April 10, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | Cancer Hospital Affiliate to Zhengzhou University & Henan Cancer Hospital | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Henan Cancer Hospital | The Pregene (ShenZhen) Biotechnology Company, Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | occurrence of study related adverse events | safety of CAR-T cells | 4 weeks | |
Secondary | Treatment response rate | response rate according to IMWG criteria | 3 months and 6 months | |
Secondary | copy number of CAR-T cells | copy number of CAR-T cells | one year |