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NCT Number: NCT07628582

A Study of the LVIVO-TaVec122 Product in Subjects With Relapsed/Refractory B-cell Malignancies

This is a single-arm, open-label and dose-escalation clinical study to evaluate the LVIVO-TaVec122 product in adult subjects with Relapsed/Refractory B-cell Malignancies.

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Key information

Conditions

Relapsed/Refractory B-cell Malignancies Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location contact

Lei Fan, Doctor

CONTACT

[email protected]

13813976136 ext. +186

About this study

This is a single-arm, open-label clinical study to evaluate the safety, tolerability and efficacy of LVIVO-TaVec122 product in adult subjects with Relapsed/Refractory B-cell Malignancies. Subjects who meet the defined eligibility criteria will be enrolled with a core study period of approximately 2 years, including the screening, bridging therapy(if needed), treatment, and follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects voluntary agreement to provide written informed consent.
  • Age ≥ 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • At least one evaluable tumor lesion.
  • Relapsed and/or refractory Non-Hodgkin Lymphoma (NHL) , and relapsed and/or refractory Chronic Lymphocytic Leukemia (CLL) with treatment indications.
  • Clinical laboratory values meet screening visit criteria.
  • Adequate organ function.

Exclusion criteria

  • Prior antitumor therapy with insufficient washout period.
  • Prior treatment with allo-Hematopoietic stem cell transplantation (HSCT) or gene therapies.
  • 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).
  • Known life-threatening allergic reaction, hypersensitivity reaction, or intolerance to study drug excipients and related excipients, including but not limited to Human Albumin, 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).
  • Female subjects who were pregnant, breastfeeding.
  • Any condition deemed by the investigator as rendering the subject unsuitable for participation in this study.

Treatment and study plan

LVIVO-TaVec122 product

Biological

Prior to infusion of the LVIVO-TaVec122 product, subjects will receive bridging therapy if needed.

Primary outcomes

  1. Incidence, severity, and type of treatment-emergent adverse events (TEAEs)

    Time frame: Through study completion, an average of 2 years after LVIVO-TaVec122 infusion (Day 1)

    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.

  2. Pharmacokinetics in peripheral blood

    Time frame: Through study completion, an average of 2 years after LVIVO-TaVec122 infusion (Day 1)

    CAR positive T cells and CAR transgene percentage of in peripheral blood after LVIVO-TaVec122 infusion.

  3. Pharmacokinetics in bone marrow

    Time frame: Through study completion, an average of 2 years after LVIVO-TaVec122 infusion (Day 1)

    CAR positive T cells and CAR transgene percentage of in bone marrow after LVIVO-TaVec122 infusion.

  4. The recommended Phase II dose (RP2D) for the treatment of this research

    Time frame: Through study completion, an average of 2 years after LVIVO-TaVec122 infusion (Day 1)

    RP2D established through BF-BOIN design and the dose-limiting toxicity (DLT) occurring following LVIVO-TaVec122 infusion

Secondary outcomes

  1. Overall Response Rate (ORR)

    Time frame: Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1)

    Objective Response Rate (ORR) is defined as the proportion of subjects who achieve CR or PR after treatment via LVIVO-TaVec122 infusion

  2. Progression-free survival (PFS)

    Time frame: Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1)

    Progression Free Survival (PFS) is defined as the time from the date of first infusion of the LVIVO-TaVec122 to the first documented disease progression or death, whichever occurs first

  3. Overall Survival (OS)

    Time frame: Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1)

    Overall Survival (OS) is defined as the time from the date of first infusion of LVIVO-TaVec122 to death of the subject

  4. Time to Response (TTR)

    Time frame: Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1)

    Time to Response (TTR) is defined as the time from the date of first infusion of LVIVO-TaVec122 to the date of the first response evaluation of the subject who has met all criteria for CR or PR

  5. Duration of Response (DoR)

    Time frame: Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1)

    Duration of Remission (DoR) is defined as the time from the first documentation of remission (CR or PR) to the first documented relapse evidence of the responders

  6. Immunogenicity assessment of LVIVO-TaVec122 infusion

    Time frame: Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1)

    The incidence of Anti-LVIVO-TaVec122 antibody in patients who received LVIVO-TaVec122 infusion

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Collaborators

  • Nanjing Legend Biotech Co.

Registry information

Official study title

An Open-label Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the LVIVO-TaVec122 Product in Subjects With Relapsed/Refractory B-cell Malignancies

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Jun 5, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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