LVIVO-TaVec100 for relapsed or refractory B-cell malignancies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label Phase 1 trial uses a dose-escalation followed by a dose-extension design to administer a single dose of LVIVO-TaVec100 to adults with relapsed or refractory B-cell malignancies. Eligible participants (aged 18–65, ECOG 0–1, with at least one measurable lesion and adequate organ function) undergo screening, any needed bridging therapy, treatment, and follow-up. The study is conducted at multiple hospital sites in China and focuses on safety, tolerability, and early signs of anti-tumor activity after the single administration. Dose escalation will identify tolerable dose levels before expanding at selected doses to gather additional safety and efficacy information.

Why it matters

Who can join: the full rules

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 greater than or equal to 18.
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 lentiviral vector-based gene therapies;
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. Lactating women;

Where it's running

• The First Affiliated Hospital of USTC west district
  Hefei, Anhui, China Recruiting
• Beijing Gobroad Boren Hospita
  Beijing, Beijing Municipality, China Recruiting
• The Fourth Hospital of Hebei Medical University
  Shijiazhuang, Hebei, China Recruiting
• Union Hospital Tongji Medical College Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting
• The First Affiliated Hospital with Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting
• The First Affiliated Hospital of ZHENGZHOU University
  Zhengzhou, Henan, China Not yet recruiting

Study contacts

• Study coordinator: FAN Lei
• Email: fanlei3014@126.com
• Phone: 13813976136

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.