The LVIVO-TaVec100 Product in the Treatment of Relapsed/Refractory B-cell Malignancies
NCT ID: NCT07002112
Last Updated: 2025-08-12
Study Results
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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RECRUITING
PHASE1
30 participants
INTERVENTIONAL
2025-05-23
2029-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
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.
LVIVO-TaVec100 product
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.
Eligibility Criteria
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Inclusion Criteria
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
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;
18 Years
65 Years
ALL
No
Sponsors
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Nanjing Legend Biotech Co.
INDUSTRY
The First Affiliated Hospital with Nanjing Medical University
OTHER
Responsible Party
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Lei Fan
Director of lymphoma center
Locations
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The First Affiliated Hospital of USTC west district
Hefei, Anhui, China
Beijing Gobroad Boren Hospita
Beijing, Beijing Municipality, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The First Affiliated Hospital of ZHENGZHOU University
Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LB2409-0001
Identifier Type: -
Identifier Source: org_study_id
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