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Not yet recruiting NCT07399444

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

Early Phase I Interventional Multiple Myeloma (MM)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LVIVO-TaVec400 product.
Who it may be relevant to
Registry conditions: Multiple Myeloma (MM). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of the LVIVO-TaVec400 Product in the Treatment of Relapsed/Refractory Multiple Myeloma

Overview

This is a prospective, single-arm, open-label dose-escalation clinical study to evaluate LVIVO-TaVec400 in the treatment of relapsed/refractory multiple myeloma.

Detailed description

This is a prospective, single-arm, open-label dose-escalation and dose-expansion study, designed to evaluate the safety, tolerability, anti-tumor efficacy profile, and pharmacokinetic characteristics of the LVIVO-TaVec400 in subjects with relapsed/refractory multiple myeloma who have failed at least 3 lines of prior standard therapies. The subject who meet the defined eligibility criteria will be enrolled with a core study period of approximately 2 years, including the screening, bridging therapy(if needed), treatment, and follow-up.

Interventions

  • Biological LVIVO-TaVec400 product
    Prior to infusion of the LVIVO-TaVec400 product, subjects will receive bridging therapy if needed.

Primary outcome measures

  • Dose-limiting toxicity (DLT) incidence rate and the incidence, severity and type of adverse events (TEAEs) during treatment. [Time frame: 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. [Time frame: Through study completion, an average of 2 years after LVIVO-TaVec400 infusion (Day 1)]
  • Pharmacokinetics in peripheral blood [Time frame: Through study completion, an average of 2 years after LVIVO-TaVec400 infusion (Day 1)]
  • Pharmacokinetics in bone marrow [Time frame: Through study completion, an average of 2 years after LVIVO-TaVec400 infusion (Day 1)]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 6 centers
  • Henan Cancer Hospital — Zhengzhou
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
  • The Affiliated Hospital of Xuzhou Medical University — Xuzhou
  • The First Affiliated Hospital of Nanchang University — Nanchang
  • Beijing GoBroad Boren Hospital — Beijing
  • Institute of Hematology & Blood Diseases Hospital — Tianjin

Identifiers

NCT: NCT07399444 · IIT2025143

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗