A Study of the LVIVO-TaVec122 Product in Subjects With Relapsed/Refractory B-cell Malignancies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LVIVO-TaVec122 product.
- Who it may be relevant to
- Registry conditions: Relapsed/Refractory B-cell Malignancies. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
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.
Interventions
- Biological LVIVO-TaVec122 product
Prior to infusion of the LVIVO-TaVec122 product, subjects will receive bridging therapy if needed.
Primary outcome measures
- 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)]
- Pharmacokinetics in peripheral blood [Time frame: Through study completion, an average of 2 years after LVIVO-TaVec122 infusion (Day 1)]
- Pharmacokinetics in bone marrow [Time frame: 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 [Time frame: Through study completion, an average of 2 years after LVIVO-TaVec122 infusion (Day 1)]
Secondary outcome measures (6)
- Overall Response Rate (ORR) [Time frame: Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1)]
- Progression-free survival (PFS) [Time frame: Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1)]
- Overall Survival (OS) [Time frame: Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1)]
- Time to Response (TTR) [Time frame: Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1)]
- Duration of Response (DoR) [Time frame: Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1)]
- Immunogenicity assessment of LVIVO-TaVec122 infusion [Time frame: Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital with Nanjing Medical University — Nanjing
Identifiers
NCT: NCT07628582 · LB2601-0001