LVIVO-TaVec200 for relapsed or 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

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
• Enrollment: 36 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Locations: 5 sites (Zhengzhou, Henan and 4 other locations)
• Trial ID: NCT07294625 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Zhengzhou, Henan and 4 other locations

• Henan Cancer Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• The First Affiliated Hospital with Nanjing Medical University — Nanjing, Jiangsu, China (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

Conditions Multiple Myeloma; Relapsed/Refractory multiple myeloma