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GLPG CAR T-cell therapy

Phase 3

Hematological Malignancies | Gene therapy | Other |Galapagos NV|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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment546
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06652633Long-term Follow-up of Participants Treated With Galapagos Chimeric Antigen Receptor (CAR) T-cell TherapiesPHASE3 RECRUITING 546 — — Sep 9, 2024Jul 1, 2039Jun 8, 202611 United States, Belgium +3
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Study Endpoints
Primary Endpoints
Percentage of participants with targeted adverse events (AEs)
From infusion up to 15 years
Percentage of participants with detectable CAR transgene levels in peripheral blood
From infusion up to 15 years
Percentage of participants with serious AEs (SAEs) considered related to the Galapagos CAR T-cell therapy
From infusion up to 15 years
Percentage of participants with at least 1% of T-cells in the blood sample or positive new malignancies
From infusion up to 15 years
Percentage of participants with detectable replication-competent lentivirus (RCL) in peripheral blood
From infusion up to 15 years
Percentage of participants who died with causes
From infusion up to 15 years
Secondary Endpoints
Percentage of participants with disease progression
From infusion up to 15 years
Time to subsequent anticancer therapy
From infusion up to 15 years
Overall survival
From infusion up to 15 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
Previously treated participants with GLPG CAR T-cell therapyEXPERIMENTALAll participants who have been treated with a Galapagos CAR T-cell therapy
Interventions
NameTypeDescription
GLPG CAR T-cell therapyGENETICNo investigational products will be administered to participants in this study.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * All participants who have been treated with a Galapagos CAR T-cell therapy in a clinical trial or Managed Access Program. Exclusion Criteria: * There are no exclusion criteria for this study

Countries:United StatesBelgiumFinlandNetherlandsSpain
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Recent Changes (Last 90 Days)
LOWJun 8, 2026NCT06652633lastUpdatePostDate: changed
LOWJun 8, 2026NCT06652633lastUpdatePostDate: changed
LOWJun 8, 2026NCT06652633lastUpdatePostDate: changed
LOWMay 26, 2026NCT06652633primaryCompletionDate: changed
LOWMay 24, 2026NCT06652633studyFirstPostDate: changed