A Phase 1 interventional study of LVIVO-TaVec122 product in Relapsed/Refractory B-cell Malignancies, sponsored by The First Affiliated Hospital with Nanjing Medical University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-05.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Phase 1, Interventional, and Treatment
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.
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.
4,278 studies on the registry are indexed under Recurrence; 987 are open to participants now.
This study's planned enrollment of 48 is close to the median of 50 across 3,373 interventional studies indexed under Recurrence.
Browse Recurrence studies →The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
Time frame: 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.
Time frame: 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.
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
RP2D established through BF-BOIN design and the dose-limiting toxicity (DLT) occurring following LVIVO-TaVec122 infusion
Time frame: Through study completion, an average of 2 years after LVIVO-TaVec122 infusion (Day 1)
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1)
Plan to share: No
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The First Affiliated Hospital with Nanjing Medical University