A Clinical Study to Evaluate LVIVO-TaVec400 for the Treatment of Relapsed/Refractory Multiple Myeloma（LB2505-0001）
LB2505-0001
A Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of the LVIVO-TaVec400 Product in the Treatment of Relapsed/Refractory Multiple Myeloma
1 other identifier
interventional
38
1 country
6
Brief Summary
This is a prospective, single-arm, open-label dose-escalation clinical study to evaluate LVIVO-TaVec400 in the treatment of relapsed/refractory multiple myeloma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Jan 2026
Longer than P75 for early_phase_1
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 10, 2026
CompletedFirst Submitted
Initial submission to the registry
January 25, 2026
CompletedFirst Posted
Study publicly available on registry
February 10, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 10, 2030
February 10, 2026
February 1, 2026
2.5 years
January 25, 2026
February 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Dose-limiting toxicity (DLT) incidence rate and the incidence, severity and type of adverse events (TEAEs) during treatment.
Through study completion, an average of 2 years after LVIVO-TaVec400 infusion (Day 1)
Determine the recommended dose (RP2D) for the treatment of this research formulation in the Phase II clinical trial.
Through study completion, an average of 2 years after LVIVO-TaVec400 infusion (Day 1)
Pharmacokinetics in peripheral blood
CAR positive T cells and CAR transgene percentage of in peripheral blood after LVIVO-TaVec400 infusion
Through study completion, an average of 2 years after LVIVO-TaVec400 infusion (Day 1)
Pharmacokinetics in bone marrow
CAR positive T cells and CAR transgene percentage of in bone marrow after LVIVO-TaVec400 infusion
Through study completion, an average of 2 years after LVIVO-TaVec400 infusion (Day 1)
Study Arms (1)
LVIVO-TaVec400 product
EXPERIMENTALEach subject will be given a single-dose LVIVO-TaVec400 product infusion at each dose level
Interventions
Prior to infusion of the LVIVO-TaVec400 product, subjects will receive bridging therapy if needed.
Eligibility Criteria
You may qualify if:
- 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
- Relapsed and/or refractory multiple myeloma
- Life expectancy≥ 3 months
- Clinical laboratory values meet screening visit criteria
- Adequate organ function.
You may not qualify if:
- 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.
- Also enrolled in other clinical studies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Henan Cancer Hospital
Zhengzhou, Henan, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Beijing GoBroad Boren Hospital
Beijing, China
Institute of Hematology & Blood Diseases Hospital
Tianjin, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lugui Qiu
Institute of Hematology & Blood Diseases Hospital, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2026
First Posted
February 10, 2026
Study Start
January 10, 2026
Primary Completion (Estimated)
July 10, 2028
Study Completion (Estimated)
May 10, 2030
Last Updated
February 10, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share