A Clinical Study to Evaluate LVIVO-TaVec400 for the Treatment of Relapsed/Refractory Multiple Myeloma(LB2505-0001)

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

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

38 Participants
are divided into 1 treatment group

Locations

6
Henan Cancer Hospital ZhengzhouHenan, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology WuhanHubei, China
The Affiliated Hospital of Xuzhou Medical University XuzhouJiangsu, China
The First Affiliated Hospital of Nanchang University NanchangJiangxi, China

Sponsors and collaborators

Institute of Hematology & Blood Diseases Hospital, China

Lead sponsor

Nanjing Legend Biotech Co.

Collaborator