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Rapcabtagene autoleucel single agent

Phase 1

Chronic Lymphocytic Leukemia | Monoclonal antibody | Oncology |Novartis AG|Last Updated: Jun 4, 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
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment217
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03960840Phase I/II Study of Rapcabtagene Autoleucel in CLL, 3L+ DLBCL, r/r ALL and 1L HR LBCLPHASE1 ACTIVE NOT_RECRUITING 217 — — Jun 26, 2019May 31, 2028Jun 4, 202637 United States, Australia +6
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Study Endpoints
Primary Endpoints
Phase 1: Dose recommendation: Incidence and nature of Dose Limiting Toxicities (Dose Escalation part only)
28 days
Phase 1: Safety: Incidence and severity of AEs and SAEs, including changes in laboratory values, ECG and vital signs
24 months
Phase 1: Tolerability: Ibrutinib dose modifications in the CLL/SLL arm
24 months
Phase 1: Manufacture success: Number of patients infused with planned target dose
24 months
Phase 2: Complete Response Rate (CRR) as assessed by local Investigator
24 months

CRR defined as best overall response (BOR) of CR after rapcabtagene autoleucel infusion as per Lugano criteria for 3L+ Diffuse Large B-Cell Lymphoma (DLBCL) and 1L High Risk Large B-Cell (HR LBCL)

Secondary Endpoints
Phase 1: Complete Response (CR)/Partial Response (CR) in CLL/SLL
24 months
Phase 1: BOR of CR/PR per Lugano criteria in 3L+ DLBCL
24 months
Phase 1: Duration of response (DOR) in CLL/SLL and 3L+ DLBCL
24 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CLL/SLLEXPERIMENTALDose escalation of rapcabtagene autoleucel in combination with ibrutinib
3L+ DLBCLEXPERIMENTALDose escalation and expansion of rapcabtagene autoleucel single agent in 3L+ DLBCL
Adult ALLEXPERIMENTALDose escalation of rapcabtagene autoleucel single agent in adult ALL
1L HR LBCLEXPERIMENTALRapcabtagene autoleucel single agent in 1L HR LBCL
Interventions
NameTypeDescription
Rapcabtagene autoleucel single agentBIOLOGICALSingle infusion of rapcabtagene autoleucel
IbrutinibDRUGTablets or capsules for oral daily use
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Eligibility Criteria
Age Range18 Years — 100 Years
SexALL
Healthy VolunteersNo
Study Sites37

Inclusion Criteria: * ECOG performance status 0-1 for ALL and DLBCL * ECOG performance status 0-2 for 1L HR LBCL at screening * CLL or SLL diagnosis according to iwCLL criteria * CLL/SLL in SD or PR after at least 6 months of ibrutinib, either as second or subsequent line of therapy * DLBCL diagnos...

Countries:United StatesAustraliaAustriaFranceGermanyItalyJapanSpain
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Recent Changes (Last 90 Days)
MEDIUMJun 4, 2026NCT03960840Completion: 2027-06-30 → 2028-05-31
MEDIUMJun 4, 2026NCT03960840Completion: 2027-06-30 → 2028-05-31
MEDIUMJun 4, 2026NCT03960840Completion: 2027-06-30 → 2028-05-31
MEDIUMJun 4, 2026NCT03960840Completion: 2027-06-30 → 2028-05-31
LOWMay 26, 2026NCT03960840primaryCompletionDate: changed
LOWMay 24, 2026NCT03960840studyFirstPostDate: changed