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

This is a prospective, single-arm, open-label dose-escalation clinical study to evaluate LVIVO-TaVec200 in the treatment of relapsed/refractory multiple myeloma.

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Biological: LVIVO-TaVec200 product

Detailed Description

This is a prospective, single-arm, open-label dose-escalation and dose-expansion study, designed to evaluate the safety, tolerability, anti-tumor efficacy profile, and pharmacokinetic characteristics of the LVIVO-TaVec200 in subjects with relapsed/refractory multiple myeloma who have failed at least 3 lines of prior standard therapies. The subject who meet the defined eligibility criteria will be enrolled with a core study period of approximately 2 years, including the screening, bridging therapy(if needed), treatment, and follow-up.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Lijuan Chen; Phone Number: 025-68306091; Email: chenljb@126.com
• Study Contact Backup: Name: Xuxing Shen; Phone Number: 025-68306091; Email: ruxiaoguo1992@163.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China
      • Not yet recruiting
      • Henan Cancer Hospital
      • Contact: Baijun Fang
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • The First Affiliated Hospital with Nanjing Medical University
      • Principal Investigator: Lei FAN
      • Contact: Xuxing Shen; Phone Number: 025-68306091; Email: ruxiaoguo1992@163.com
      • Principal Investigator: Lijuan Chen
    • Xuzhou, Jiangsu, China
      • Not yet recruiting
      • The Affiliated Hospital of Xuzhou Medical University
      • Contact: Huanxin Li
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Not yet recruiting
      • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
      • Contact: Jianqing Mi
  • Shanxi
    • Xi’an, Shanxi, China
      • Not yet recruiting
      • The Second Affiliated Hospital of Xi'an Jiaotong University
      • Contact: Wanhong Zhao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LVIVO-TaVec200 product; Each subject will be given a single-dose LVIVO-TaVec200 product infusion at each dose level	Biological: LVIVO-TaVec200 product; Prior to infusion of the LVIVO-TaVec200 product, subjects will receive bridging therapy if needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Collaborators: Nanjing Legend Biotech Co.

Study record dates

Study Major Dates

• Study Start (Estimated): December 10, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2029

Study Registration Dates

• First Submitted: December 8, 2025
• First Submitted That Met QC Criteria: December 8, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Relapsed/Refractory multiple myeloma
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma
• Other Study ID Numbers: LB2503-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No