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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Relapsed/Refractory B-cell Malignancies
• Intervention / Treatment: Biological: LVIVO-TaVec122 product

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • The First Affiliated Hospital with Nanjing Medical University
      • Contact: Lei Fan, Doctor; Phone Number: +186 13813976136; Email: fanlei3014@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Prior antitumor therapy with insufficient washout period.
2. Prior treatment with allo-Hematopoietic stem cell transplantation (HSCT) or 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 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).
5. Female subjects who were pregnant, breastfeeding.
6. Any condition deemed by the investigator as rendering the subject unsuitable for participation in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LVIVO-TaVec122 product; Each subject will be given a single-dose LVIVO-TaVec122 product infusion at each dose level.	Biological: LVIVO-TaVec122 product; Prior to infusion of the LVIVO-TaVec122 product, subjects will receive bridging therapy if needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence, severity, and type of treatment-emergent adverse events (TEAEs)	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.	Through study completion, an average of 2 years after LVIVO-TaVec122 infusion (Day 1)
Pharmacokinetics in peripheral blood	CAR positive T cells and CAR transgene percentage of in peripheral blood after LVIVO-TaVec122 infusion.	Through study completion, an average of 2 years after LVIVO-TaVec122 infusion (Day 1)
Pharmacokinetics in bone marrow	CAR positive T cells and CAR transgene percentage of in bone marrow after LVIVO-TaVec122 infusion.	Through study completion, an average of 2 years after LVIVO-TaVec122 infusion (Day 1)
The recommended Phase II dose (RP2D) for the treatment of this research	RP2D established through BF-BOIN design and the dose-limiting toxicity (DLT) occurring following LVIVO-TaVec122 infusion	Through study completion, an average of 2 years after LVIVO-TaVec122 infusion (Day 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR)	Objective Response Rate (ORR) is defined as the proportion of subjects who achieve CR or PR after treatment via LVIVO-TaVec122 infusion	Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1)
Progression-free survival (PFS)	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	Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1)
Overall Survival (OS)	Overall Survival (OS) is defined as the time from the date of first infusion of LVIVO-TaVec122 to death of the subject	Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1)
Time to Response (TTR)	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	Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1)
Duration of Response (DoR)	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	Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1)
Immunogenicity assessment of LVIVO-TaVec122 infusion	The incidence of Anti-LVIVO-TaVec122 antibody in patients who received LVIVO-TaVec122 infusion	Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1)

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Collaborators: Nanjing Legend Biotech Co.

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): September 30, 2030

Study Registration Dates

• First Submitted: June 1, 2026
• First Submitted That Met QC Criteria: June 4, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: B-cell malignancies
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Recurrence
• Other Study ID Numbers: LB2601-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No