Clinical trial · Interventional
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
NCT07628582CI-TRIAL-00113870not yet recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed/Refractory B-cell Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LVIVO-TaVec122 product | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LVIVO-TaVec122 product
- description
- Each subject will be given a single-dose LVIVO-TaVec122 product infusion at each dose level.
- interventionNames
- Biological: LVIVO-TaVec122 product
Primary outcomes (4)
- measure
- Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
- timeFrame
- Through study completion, an average of 2 years after LVIVO-TaVec122 infusion (Day 1)
- description
- 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.
- measure
- Pharmacokinetics in peripheral blood
- timeFrame
- Through study completion, an average of 2 years after LVIVO-TaVec122 infusion (Day 1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.