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LVIVO-TaVec122 product

Phase 1

Relapsed/Refractory B-cell Malignancies | Monoclonal antibody | Other |Legend Biotech Corporation|Last Updated: Jun 5, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07628582A Study of the LVIVO-TaVec122 Product in Subjects With Relapsed/Refractory B-cell MalignanciesPHASE1 NOT YET_RECRUITING 48Sep 15, 2026Sep 30, 2030Jun 5, 20261 China
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Study Endpoints
Primary Endpoints
Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
Through study completion, an average of 2 years after LVIVO-TaVec122 infusion (Day 1)

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.

Pharmacokinetics in peripheral blood
Through study completion, an average of 2 years after LVIVO-TaVec122 infusion (Day 1)

CAR positive T cells and CAR transgene percentage of in peripheral blood after LVIVO-TaVec122 infusion.

Pharmacokinetics in bone marrow
Through study completion, an average of 2 years after LVIVO-TaVec122 infusion (Day 1)

CAR positive T cells and CAR transgene percentage of in bone marrow after LVIVO-TaVec122 infusion.

The recommended Phase II dose (RP2D) for the treatment of this research
Through study completion, an average of 2 years after LVIVO-TaVec122 infusion (Day 1)

RP2D established through BF-BOIN design and the dose-limiting toxicity (DLT) occurring following LVIVO-TaVec122 infusion

Secondary Endpoints
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)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LVIVO-TaVec122 productEXPERIMENTALEach subject will be given a single-dose LVIVO-TaVec122 product infusion at each dose level.
Interventions
NameTypeDescription
LVIVO-TaVec122 productBIOLOGICALPrior to infusion of the LVIVO-TaVec122 product, subjects will receive bridging therapy if needed.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

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/...

Countries:China
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