LVIVO-TaVec200 for relapsed or refractory multiple myeloma
Official title: A Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of the LVIVO-TaVec200 Product in the Treatment of Relapsed/Refractory Multiple Myeloma
Run by The First Affiliated Hospital with Nanjing Medical University · NCT07294625 · Data updated 2026-11-12
This trial will try LVIVO-TaVec200, a new investigational product, in adults with relapsed or refractory multiple myeloma who have received at least three prior therapies.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Locations | 5 sites (Zhengzhou, Henan and 4 other locations) |
| Status | Recruiting |
| Started | December 10, 2025 |
| Main results expected | March 31, 2027 |
| Study ends | March 31, 2029 |
| Registry record updated | December 19, 2025 |
| Trial ID | NCT07294625 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults (≥18 years) with measurable relapsed or refractory multiple myeloma, ECOG performance status 0–1, adequate organ function, and at least three prior lines of therapy.
✕Probably not a fit
Patients previously treated with therapies targeting GPRC5D or those with active hepatitis B, hepatitis C, or HIV infection, poor performance status, or inadequate organ function are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, single-arm, open-label dose-escalation and dose-expansion trial testing LVIVO-TaVec200 in patients with relapsed or refractory multiple myeloma. The study will characterize safety, tolerability, anti-tumor activity, and pharmacokinetics of the investigational product. Eligible participants must have measurable disease, ECOG 0–1, adequate organ function, and prior failure of at least three standard treatment lines. The core study period is approximately two years and includes screening, bridging therapy if needed, treatment, and follow-up.
Why it matters
Potential benefit: If successful, LVIVO-TaVec200 could provide a new treatment option that induces responses in patients who have exhausted standard therapies.
How similar studies have gone: Other GPRC5D-targeting approaches such as bispecific antibodies and CAR-T therapies have shown promising responses in heavily pretreated multiple myeloma, but LVIVO-TaVec200 itself is a novel investigational agent with limited prior data.
Who can join: the full rules
Show full inclusion / exclusion criteria
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. Prior treatment targeting GPRC5D; 3. 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). 4. 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). 5. Any condition deemed by the investigator as rendering the subject unsuitable for participation in this study.
Where it's running
-
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China Recruiting -
Henan Cancer Hospital
Zhengzhou, Henan, China Not yet recruiting -
The Affiliated Hospital of XUZHOU Medical University
Xuzhou, Jiangsu, China Not yet recruiting -
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China Not yet recruiting -
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China Not yet recruiting
Study contacts
- Study coordinator: Lijuan Chen
- Email: chenljb@126.com
- Phone: 025-68306091
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.