Clinical trial · Interventional
A Clinical Study to Evaluate LVIVO-TaVec400 for the Treatment of Relapsed/Refractory Multiple Myeloma（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
NCT07399444CI-TRIAL-00102890LB2505-0001not yet recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective, single-arm, open-label dose-escalation clinical study to evaluate LVIVO-TaVec400 in the treatment of relapsed/refractory multiple myeloma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma (MM) | Multiple Myeloma | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LVIVO-TaVec400 product | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LVIVO-TaVec400 product
- description
- Each subject will be given a single-dose LVIVO-TaVec400 product infusion at each dose level
- interventionNames
- Biological: LVIVO-TaVec400 product
Primary outcomes (4)
- measure
- Dose-limiting toxicity (DLT) incidence rate and the incidence, severity and type of adverse events (TEAEs) during treatment.
- timeFrame
- Through study completion, an average of 2 years after LVIVO-TaVec400 infusion (Day 1)
- measure
- Determine the recommended dose (RP2D) for the treatment of this research formulation in the Phase II clinical trial.
- timeFrame
- Through study completion, an average of 2 years after LVIVO-TaVec400 infusion (Day 1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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. 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: 1. Prior antitumor therapy with insufficient washout period ; 2. 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). 3. 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). 4. Any condition deemed by the investigator as rendering the subject unsuitable for participation in this study. 5. Also enrolled in other clinical studies.
References
Publications (0)
Data not yet available
No reference posted for this study.