This is a prospective, single-arm, open-label dose-escalation clinical study to evaluate LVIVO-TaVec400 in the treatment of relapsed/refractory multiple myeloma.
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
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.
Single group
LVIVO-TaVec400 product
Biological/VaccinePrior to infusion of the LVIVO-TaVec400 product, subjects will receive bridging therapy if needed.
Dose-limiting toxicity (DLT) incidence rate and the incidence, severity and type of adverse events (TEAEs) during treatment.
Determine the recommended dose (RP2D) for the treatment of this research formulation in the Phase II clinical trial.
Pharmacokinetics in peripheral blood
CAR positive T cells and CAR transgene percentage of in peripheral blood after LVIVO-TaVec400 infusion
Pharmacokinetics in bone marrow
CAR positive T cells and CAR transgene percentage of in bone marrow after LVIVO-TaVec400 infusion
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Institute of Hematology & Blood Diseases Hospital, China
Lead sponsor
Nanjing Legend Biotech Co.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
