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

NCT ID: NCT07002112

Last Updated: 2025-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-23

Study Completion Date

2029-06-30

Brief Summary

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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.

Detailed Description

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This is an open-label, dose-escalation/dose extension study to assess the safety, tolerability, and efficacy of LVIVO-TaVec100 product in the patient ≥ 18 years of age with relapsed or refractory B-cell Malignancies. Subjects who meet the eligibility criteria will receive a single dose of LVIVO-TaVec100 product. The study will include the following sequential phases: screening, bridging therapy (if needed), treatment, and follow-up.

Conditions

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Relapsed/Refractory B-cell Malignancies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LVIVO-TaVec100 product

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

Group Type EXPERIMENTAL

LVIVO-TaVec100 product

Intervention Type BIOLOGICAL

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

Interventions

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LVIVO-TaVec100 product

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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

Exclusion Criteria

Subject eligible for this study must not meet any of the following criteria:

1. Prior antitumor therapy with insufficient washout period ;
2. Prior treatment with other autologous cells or gene therapies other than targeting CD19 autologous CAR-T;
3. 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).
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. Lactating women;
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing Legend Biotech Co.

INDUSTRY

Sponsor Role collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Lei Fan

Director of lymphoma center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The First Affiliated Hospital of USTC west district

Hefei, Anhui, China

Site Status RECRUITING

Beijing Gobroad Boren Hospita

Beijing, Beijing Municipality, China

Site Status RECRUITING

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status RECRUITING

The First Affiliated Hospital of ZHENGZHOU University

Zhengzhou, Henan, China

Site Status NOT_YET_RECRUITING

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status RECRUITING

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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FAN Lei

Role: CONTACT

13813976136 ext. +86

Facility Contacts

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Kaiyang DING

Role: primary

13966672170 ext. +86

Yajing ZHANG

Role: primary

18601333856 ext. +86

Haisheng LIU

Role: primary

13933078299 ext. +86

Yi Zhang

Role: primary

15138928971 ext. +86

Heng MEI

Role: primary

13886160811 ext. +86

Lei FAN

Role: primary

13813976136 ext. +186

Other Identifiers

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LB2409-0001

Identifier Type: -

Identifier Source: org_study_id

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