Actively Recruiting
A Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of the LVIVO-TaVec200 Product in the Treatment of Relapsed/Refractory Multiple Myeloma
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-12-19
36
Participants Needed
5
Research Sites
104 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital with Nanjing Medical University
Lead Sponsor
N
Nanjing Legend Biotech Co.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the LVIVO-TaVec200 product in a dose-escalation and dose-expansion clinical study for adults with relapsed or refractory multiple myeloma who have not responded to at least three prior standard treatments. This early phase 1 study aims to assess the safety, tolerability, anti-tumor effects, and how the product behaves in the body over time. The study is open-label and single-arm, focusing on this specific patient group with measurable disease and a reasonable life expectancy. Participants will receive a single infusion of the LVIVO-TaVec200 product at increasing dose levels. Before the infusion, some participants may receive bridging therapy if needed. The study includes a core period lasting about two years, which covers screening, bridging therapy, treatment, and follow-up phases. Researchers will monitor patients closely throughout this time to determine the recommended dose for future studies. During the study, participants will undergo various assessments, including monitoring for treatment-emergent adverse events, and testing the pharmacokinetics of the product in peripheral blood and bone marrow. These evaluations will continue through the two-year follow-up period after infusion. Participants will be regularly assessed for safety and treatment effects, with ongoing follow-up to track their response and health status throughout the study duration.
CONDITIONS
Brief Title
A Clinical Study to Evaluate LVIVO-TaVec200 for the Treatment of Relapsed/Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects voluntarily participate and sign informed consent before any study-related procedures
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Measurable lesions present
- Relapsed and/or refractory multiple myeloma
- Life expectancy of at least 3 months
- Clinical laboratory values meet screening criteria
- Adequate organ function
You will not qualify if you...
- Prior antitumor therapy with insufficient washout period
- Prior treatment targeting GPRC5D
- Positive for hepatitis B surface antigen, hepatitis B DNA, hepatitis C antibody, hepatitis C RNA, or HIV antibody
- Known life-threatening allergic or hypersensitivity reactions to the study drug or its components, including severe immune-related reactions
- Any condition deemed unsuitable by the investigator for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Variable, depending on participant needs
Participants may receive bridging therapy prior to the LVIVO-TaVec200 product infusion if needed.
Duration - Approximately 30 days after infusion for dose evaluation, with continued monitoring up to 2 years
Participants receive a single-dose infusion of the LVIVO-TaVec200 product at each dose level.
Multiple visits during the core study period of approximately 2 years
Duration - Up to 2 years after treatment
Participants are monitored for safety, tolerability, and efficacy for up to 2 years after the LVIVO-TaVec200 infusion.
Multiple follow-up visits over 2 years
Trial Site Locations
Total: 5 locations
1
Henan Cancer Hospital
Zhengzhou, Henan, China
Not Yet Recruiting
2
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
Actively Recruiting
3
The Affiliated Hospital of XUZHOU Medical University
Xuzhou, Jiangsu, China
Not Yet Recruiting
4
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
5
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Not Yet Recruiting
Research Team
L
Lijuan Chen
X
Xuxing Shen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here