Clinical trial NCT07002112: The LVIVO-TaVec100 Product in the Treatment of Relapsed/Refractory B-cell Malignancies
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Relapsed/Refractory B-cell Malignancies
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Nanjing Legend Biotech Co.
First posted: 2025-06-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This is an open-label, dose-escalation/dose extension study to assess the safety, tolerability, and efficacy of LVIVO-TaVec100 product in the patient ≥ 18 years of age with relapsed or refractory B-cell Malignancies. Subjects who meet the eligibility criteria will receive a single dose of LVIVO-TaVec100 product. The study will include the following sequential phases: screening, bridging therapy (if needed), treatment, and follow-up.

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;

Primary outcomes:
measure: Incidence, severity and type of TEAEs (Treatment-emergent Adverse Events)
timeFrame: Through study completion, an average of 2 years after LVIVO-TaVec100 infusion (Day 1)
measure: Pharmacokinetics in peripheral blood
timeFrame: Through study completion, an average of 2 years after LVIVO-TaVec100 infusion (Day 1)
measure: Pharmacokinetics in bone marrow
timeFrame: Through study completion, an average of 2 years after LVIVO-TaVec100 infusion (Day 1)
measure: The recommended Phase II dose (RP2D) for this cell therapy
timeFrame: 30 days after LVIVO-TaVec100 infusion
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Through study completion, an average 2 years after LVIVO-TaVec100 infusion (Day 1)
measure: Progression-free survival (PFS)
timeFrame: Through study completion, an average 2 years after LVIVO-TaVec100 infusion (Day 1)
measure: Overall Survival (OS)
timeFrame: Through study completion, an average 2 years after LVIVO-TaVec100 infusion (Day 1)
measure: Time to Response (TTR)
timeFrame: Through study completion, an average 2 years after LVIVO-TaVec100 infusion (Day 1)
measure: Duration of Response (DoR)
timeFrame: Through study completion, an average 2 years after LVIVO-TaVec100 infusion (Day 1)
measure: Immunogenicity assessment of LVIVO-TaVec100 infusion
timeFrame: Through study completion, an average 2 years after LVIVO-TaVec100 infusion (Day 1)
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of USTC west district
state: Anhui
city: Beijing
country: China
facility: Beijing Gobroad Boren Hospita
state: Beijing
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
state: Hebei
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of ZHENGZHOU University
state: Henan
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
Study officials:
References: