RecruitingEarly Phase 1NCT07294625
A Clinical Study to Evaluate LVIVO-TaVec200 for the Treatment of Relapsed/Refractory Multiple Myeloma
A Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of the LVIVO-TaVec200 Product in the Treatment of Relapsed/Refractory Multiple Myeloma
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Enrollment
36 participants
Start Date
Dec 10, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
This is a prospective, single-arm, open-label dose-escalation clinical study to evaluate LVIVO-TaVec200 in the treatment of relapsed/refractory multiple myeloma.
Eligibility
Min Age: 18 Years
Inclusion Criteria8
- 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 Criteria5
- Prior antitumor therapy with insufficient washout period ;
- Prior treatment targeting GPRC5D;
- 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).
- 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).
- Any condition deemed by the investigator as rendering the subject unsuitable for participation in this study.
Interventions
BIOLOGICALLVIVO-TaVec200 product
Prior to infusion of the LVIVO-TaVec200 product, subjects will receive bridging therapy if needed.
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07294625
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