A Clinical Study to Evaluate LVIVO-TaVec200 for the Treatment of Relapsed/Refractory Multiple Myeloma

NCT07294625 | Recruiting Early Phase 1

• 1 other identifier: LB2503-0001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Multiple Myeloma

Keywords

Relapsed/Refractory multiple myeloma

Outcome Measures

Primary Outcomes (4)

• Incidence, severity and type of TEAEs (Treatment-emergent Adverse Events)

  An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

  Through study completion, an average of 2 years after LVIVO-TaVec200 infusion (Day 1)

• Pharmacokinetics in peripheral blood

  CAR positive T cells and CAR transgene percentage of in peripheral blood after LVIVO-TaVec200 infusion

  Through study completion, an average of 2 years after LVIVO-TaVec200 infusion (Day 1)

• Pharmacokinetics in bone marrow

  CAR positive T cells and CAR transgene percentage of in bone marrow after LVIVO-TaVec200 infusion

  Through study completion, an average of 2 years after LVIVO-TaVec200 infusion (Day 1)

• The recommended Phase II dose (RP2D) for this cell

  RP2D established through BF-BOIN design and the DLTs occurring following LVIVO-TaVec200 infusion

  30 days after LVIVO-TaVec200 infusion

Study Arms (1)

LVIVO-TaVec200 product

EXPERIMENTAL

Each subject will be given a single-dose LVIVO-TaVec200 product infusion at each dose level

Biological: LVIVO-TaVec200 product

Interventions

LVIVO-TaVec200 product BIOLOGICAL

Prior to infusion of the LVIVO-TaVec200 product, subjects will receive bridging therapy if needed.

LVIVO-TaVec200 product

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Nanjing Legend Biotech Co.: collaborator

Study Sites (5)

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

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Lijuan Chen

CONTACT

025-68306091; chenljb@126.com

Xuxing Shen

CONTACT

025-68306091; ruxiaoguo1992@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 19, 2025
• Study Start: December 10, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2029
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)