The LVIVO-TaVec100 Product in the Treatment of Relapsed/Refractory B-cell Malignancies

NCT07002112 | Recruiting Phase 1

• 1 other identifier: LB2409-0001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 6

Brief Summary

A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of the LVIVO-TaVec100 product in the Treatment of Relapsed/Refractory B-cell Malignancies.

Conditions

Relapsed/Refractory B-cell Malignancies

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-TaVec100 infusion (Day 1)

• Pharmacokinetics in peripheral blood

  CAR positive T cells and CAR transgene percentage of in peripheral blood after LVIVO-TaVec100 infusion.

  Through study completion, an average of 2 years after LVIVO-TaVec100 infusion (Day 1)

• Pharmacokinetics in bone marrow

  CAR positive T cells and CAR transgene percentage of in bone marrow after LVIVO-TaVec100 infusion.

  Through study completion, an average of 2 years after LVIVO-TaVec100 infusion (Day 1)

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

  RP2D established through 3+3 design and the DLTs occurring following LVIVO-TaVec100 infusion

  30 days after LVIVO-TaVec100 infusion

Secondary Outcomes (6)

• Overall Response Rate (ORR)

  Through study completion, an average 2 years after LVIVO-TaVec100 infusion (Day 1)

• Progression-free survival (PFS)

  Through study completion, an average 2 years after LVIVO-TaVec100 infusion (Day 1)

• Overall Survival (OS)

  Through study completion, an average 2 years after LVIVO-TaVec100 infusion (Day 1)

• Time to Response (TTR)

  Through study completion, an average 2 years after LVIVO-TaVec100 infusion (Day 1)

• Duration of Response (DoR)

  Through study completion, an average 2 years after LVIVO-TaVec100 infusion (Day 1)

Study Arms (1)

LVIVO-TaVec100 product

EXPERIMENTAL

Each subject will be given a single-dose LVIVO-TaVec100 product infusion at each dose level.

Biological: LVIVO-TaVec100 product

Interventions

LVIVO-TaVec100 product BIOLOGICAL

Prior to infusion of the LVIVO-TaVec100 product, subjects will receive bridging therapy if needed.

LVIVO-TaVec100 product

Eligibility Criteria

• Age: 18 Years - 65 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.
• Aged 18-65 years (inclusive).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• At least one evaluable tumor lesion.
• Relapsed and/or refractory NHL , and relapsed and/or refractory CLL with treatment indications
• Life expectancy≥ 3 months
• Clinical laboratory values meet screening visit criteria
• Adequate organ function;

You may not qualify if:

• Subject eligible for this study must not meet any of the following criteria:
• Prior antitumor therapy with insufficient washout period ;
• Prior treatment with other autologous cells or gene therapies other than targeting CD19 autologous CAR-T;
• Patients who are positive for hepatitis B surface antigen (HBsAg), hepatitis B virus core antibody (HBcAb), 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).
• Lactating women;

Sponsors & Collaborators

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

Study Sites (6)

The First Affiliated Hospital of USTC west district

Hefei, Anhui, 230000, China

RECRUITING

Beijing Gobroad Boren Hospita

Beijing, Beijing Municipality, 102206, China

RECRUITING

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

RECRUITING

The First Affiliated Hospital of ZHENGZHOU University

Zhengzhou, Henan, 450000, China

NOT YET RECRUITING

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

RECRUITING

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

FAN Lei

CONTACT

13813976136; fanlei3014@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of lymphoma center

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: June 3, 2025
• Study Start: May 23, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2029
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)