A Clinical Study to Evaluate LVIVO-TaVec200 for the Treatment of Relapsed/Refractory Multiple Myeloma
NCT ID: NCT07294625
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
36 participants
INTERVENTIONAL
2025-12-10
2029-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LVIVO-TaVec200 product
Each subject will be given a single-dose LVIVO-TaVec200 product infusion at each dose level
LVIVO-TaVec200 product
Prior to infusion of the LVIVO-TaVec200 product, subjects will receive bridging therapy if needed.
Interventions
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LVIVO-TaVec200 product
Prior to infusion of the LVIVO-TaVec200 product, subjects will receive bridging therapy if needed.
Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Has measurable lesions
5. Relapsed and/or refractory multiple myeloma
6. Life expectancy≥ 3 months
7. Clinical laboratory values meet screening visit criteria
8. Adequate organ function.
Exclusion Criteria
2. Prior treatment targeting GPRC5D;
3. 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).
4. Known life-threatening allergic reaction, hypersensitivity reaction, or intolerance to study drug excipients and related excipients, including but not limited to DMSO; or those with a history of severe allergic reactions in the past (such as hypersensitivity reactions, or those with severe immune-related reactions such as the need for glucocorticoids to prevent anaphylaxis as assessed by the investigator).
5. Any condition deemed by the investigator as rendering the subject unsuitable for participation in this study.
18 Years
ALL
No
Sponsors
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Nanjing Legend Biotech Co.
INDUSTRY
The First Affiliated Hospital with Nanjing Medical University
OTHER
Responsible Party
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Locations
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Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
The Affiliated Hospital of XUZHOU Medical University
Xuzhou, Jiangsu, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Countries
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Central Contacts
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Facility Contacts
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Baijun Fang
Role: primary
Xuxing Shen
Role: primary
Huanxin Li
Role: primary
Jianqing Mi
Role: primary
Wanhong Zhao
Role: primary
Other Identifiers
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LB2503-0001
Identifier Type: -
Identifier Source: org_study_id