About this trial
This is a prospective, single-arm, open-label dose-escalation clinical study to evaluate LVIVO-TaVec400 in the treatment of relapsed/refractory multiple myeloma.
Eligibility criteria
Qualifiers
Subjects voluntarily participate in clinical studies; Fully informed of this study and signed informed consent; Informed consent form must be obtained prior to initiation of any study-related tests or procedures that are not part of the standard treatment for the subject's disease; Good compliance and cooperation with follow-up.
Age ≥ 18 years.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Has measurable lesions
Disqualifiers
Prior antitumor therapy with insufficient washout period ;
Patients who are positive for hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), and human immunodeficiency virus antibody (HIV-Ab).
Those who have experienced life-threatening allergic reactions, hypersensitivity reactions or intolerances to the excipients and related additives of the investigational drug; or those with a previous history of severe allergic reactions (such as hypersensitivity reactions, or those for whom the investigator assesses the need to use glucocorticoids to prevent severe immune-related reactions such as allergic reactions).
Any condition deemed by the investigator as rendering the subject unsuitable for participation in this study.
Trial design
Treatments tested in this trial
- LVIVO-TaVec400 product
Treatment groups
Sponsors and collaborators
Institute of Hematology & Blood Diseases Hospital, China
Lead sponsor
Nanjing Legend Biotech Co.
Collaborator