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
Sponsor study identifier
interventional
48
1 country
1
Study Start
September 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 1, 2026
Actual (reported)June 5, 2026
Actual (reported)September 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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)
Overall Response Rate (ORR)
Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1)
Progression-free survival (PFS)
Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1)
Overall Survival (OS)
Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1)
Time to Response (TTR)
Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1)
Duration of Response (DoR)
Through study completion, an average 2 years after LVIVO-TaVec122 infusion (Day 1)
Each subject will be given a single-dose LVIVO-TaVec122 product infusion at each dose level.
Prior to infusion of the LVIVO-TaVec122 product, subjects will receive bridging therapy if needed.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029, China
First Submitted
June 1, 2026
First Posted
June 5, 2026
Study Start
September 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 30, 2028
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 5, 2026
Record last verified: 2026-05
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Source: ClinicalTrials.gov.
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