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LUCAR-G39D cells product

Phase 1

B-Cell Non-Hodgkin Lymphoma-Recurrent | Monoclonal antibody | Oncology |Legend Biotech Corporation|Last Updated: Nov 6, 2024

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment33
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06395870Targeting CD19/CD20 Dual-targeted Cell in Patients With Relapsed/Refractory B-cell Non-Hodgkin LymphomaPHASE1 RECRUITING 33May 9, 2024Jun 30, 2028Nov 6, 20242 China
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Study Endpoints
Primary Endpoints
Incidence, severity and type of TEAEs (Treatment-emergent Adverse Events)
Through study completion , an average of 2 years after LUCAR-G39D 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 LUCAR-G39D infusion (Day 1).

CAR positive T cells and CAR transgene levels in peripheral blood after LUCAR-G39D infusion.

Pharmacokinetics in bone marrow
Through study completion , an average of 2 years after LUCAR-G39D infusion (Day 1)

CAR positive T cells and CAR transgene levels in bone marrow after LUCAR-G39D infusion.

The recommended Phase II dose (RP2D) for this cell therapy
Within 30 days after LUCAR-G39D infusion

RP2D established through ATD+BOIN design and the DLTs occurring following CAR T-cell infusion.

Secondary Endpoints
Overall Response Rate (ORR)
Through study completion, an average of 2 years after LUCAR-G39D infusion (Day 1)
Progression-free survival (PFS)
Through study completion, an average of 2 years after LUCAR-G39D infusion (Day 1)
Overall Survival (OS)
Through study completion, an average of 2 years after LUCAR-G39D infusion (Day 1)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LUCAR-G39D cells productEXPERIMENTALEach subject will be given a single-dose LUCAR-G39D cells infusion at each dose level.
Interventions
NameTypeDescription
LUCAR-G39D cells productBIOLOGICALPrior to infusion of the LUCAR-G39D, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Subjects have fully understood the possible risks and benefits of participating in this study, are willing to follow and able to complete all trial procedures, and have signed informed consent. 2. Aged 18-75 years (inclusive). 3. Eastern Cooperative Oncology Group (ECOG) perf...

Countries:China
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06395870studyFirstPostDate: changed