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rondecabtagene autoleucel

Phase 3

Large B-cell Lymphoma | Monoclonal antibody | Oncology |Lyell Immunopharma, Inc.|Last Updated: Jun 8, 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
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment400
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07188558A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell TherapyPHASE3 RECRUITING 400Jan 12, 2026Jan 1, 2032Jun 8, 202638 United States
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Study Endpoints
Primary Endpoints
Event free survival
36 months

The time interval from treatment initiation until the occurrence of a specific event of interest.

Secondary Endpoints
Overall Response Rate
36 months
Complete Response Rate
36 months
Progression Free Survial
36 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Rondecabtagene autoleucelEXPERIMENTAL -
Investigator's Choice CD19ACTIVE_COMPARATORaxicabtagene ciloleucel, lisocabtagene maraleucel
Interventions
NameTypeDescription
rondecabtagene autoleucelBIOLOGICALAn autologous, dual-targeting CD19/20 CAR T-cell candidate.
axicabtagene ciloleucelBIOLOGICALAn autologous CD19 CAR T-cell therapy
lisocabtagene maraleucelBIOLOGICALAn autologous CD19 CAR T-cell therapy
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites38

Key Inclusion Criteria: 1. CAR T cell naïve and eligible to receive a CD19 CART-cell therapy 2. Histologically confirmed large B-cell lymphoma, including the following types defined by (WHO 2022) or International Consensus Classification (2022) * Diffuse large B-cell lymphoma (DLBCL) * Trans...

Countries:United States
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Recent Changes (Last 90 Days)
LOWJun 8, 2026NCT07188558lastUpdatePostDate: changed
LOWJun 8, 2026NCT07188558lastUpdatePostDate: changed
LOWJun 8, 2026NCT07188558lastUpdatePostDate: changed
LOWMay 26, 2026NCT07188558primaryCompletionDate: changed
LOWMay 24, 2026NCT07188558studyFirstPostDate: changed