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LCAR-HL30 cells

Phase 1

Hodgkin's Lymphoma | Monoclonal antibody | Oncology |Legend Biotech Corporation|Last Updated: Jul 10, 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 Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06494371A Study of LCAR-HL30 in Subjects With Relapsed/Refractory Hodgkin's Lymphoma and Anaplastic Large Cell LymphomaPHASE1 RECRUITING 32Jul 1, 2024Aug 1, 2028Jul 10, 20241 China
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Study Endpoints
Primary Endpoints
Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)

An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment.

Pharmacokinetics in peripheral blood
Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)

CAR positive T cells levels in peripheral blood after LCAR-HL30 infusion.

Pharmacokinetics in bone marrow
Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)

CAR positive T cells levels in bone marrow after LCAR-HL30 infusion.

Recommended Phase 2 Dose (RP2D) regimen finding
Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)

RP2D established through accelerated titration design (ATD) and Bayesian Optimal Interval (BOIN) design.

Secondary Endpoints
Objective Response Rate (ORR) after administration
Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
Time to Response (TTR) after administration
Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
Duration of Remission (DoR) after administration
Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Chimeric antigen receptor T cells LCAR-HL30 cellsEXPERIMENTALEach subject will receive LCAR-HL30 cells.
Interventions
NameTypeDescription
LCAR-HL30 cellsBIOLOGICALPrior to infusion of the LCAR-HL30, 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 Sites1

Inclusion Criteria: 1. Subjects voluntarily participate in clinical research. 2. Aged 18 to 75 years, either sex. 3. Eastern Cooperative Oncology Group (ECOG) score 0-1 (Dose escalation phase). ECOG score 0-2 (Dose expansion period). 4. Histologically confirmed Hodgkin's lymphoma or Anaplastic larg...

Countries:China
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06494371studyFirstPostDate: changed