LVIVO-TaVec100 for relapsed or refractory B-cell malignancies

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

This Phase 1 study will test a single dose of LVIVO-TaVec100 to see if it is safe and helps adults with relapsed or refractory B-cell malignancies.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Drugs / interventions: CAR-T
• Locations: 6 sites (Hefei, Anhui and 5 other locations)
• Trial ID: NCT07002112 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults 18–65 with relapsed or refractory non-Hodgkin lymphoma or chronic lymphocytic leukemia, ECOG 0–1, adequate organ function, and at least one evaluable tumor lesion.

Not a fit: Patients older than 65, with poor performance status, inadequate organ or lab function, recent anticancer therapy without required washout, or prior non‑CD19 autologous cell/gene therapies are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, LVIVO-TaVec100 could provide a new one-time cellular/gene-based treatment option for some patients who have exhausted standard therapies.

How similar studies have performed: Other gene- and cell-based therapies for B-cell cancers (such as CAR‑T) have produced durable remissions in some patients, but LVIVO-TaVec100 itself is at an early, unproven stage.

Eligibility criteria

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;

Where this trial is running

Hefei, Anhui and 5 other locations

• 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)
• The First Affiliated Hospital of ZHENGZHOU University — Zhengzhou, Henan, China (Not_yet_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)

Study contacts

• Study coordinator: FAN Lei

Conditions Relapsed/Refractory B-cell Malignancies