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N803

Phase 1

B-cell Non Hodgkin Lymphoma | Small molecule | Oncology |ImmunityBio, Inc.|Last Updated: Jan 23, 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 Enrollment13
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07049432N-803 Maintenance Therapy Post CAR T-cell Therapy in Patients With Relapsed or Refractory B-cell Non-Hodgkin LymphomasPHASE1 NOT YET_RECRUITING 13Feb 1, 2026Dec 1, 2031Jan 23, 20261 United States
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Study Endpoints
Primary Endpoints
The maximum tolerated dose (MTD) of N-803 post CAR T-cell therapy
4 years

determination of a dose level for the phase 2 study (RP2D)

Determination of a dose level for the phase 2 study (RP2D) of N-803 post CAR T-cell Therapy
4 years

determination of a dose level for the phase 2 study (RP2D)

Secondary Endpoints
The proportion of patients with a Partial Response (PR), per Lugano criteria, who achieve a Complete Response (CR) by the end of Cycle 6.
2 years
Duration of response (DoR), defined as the interval of time from the date of initial documented response (PR or CR per Lugano criteria) to the time of progression, the start of a new therapy, or death from any cause.
2 years
Progression-free survival (PFS) as defined as the time from study drug initiation to the time documented disease progression (as assessed by Lugano Criteria) or death from any cause.
2 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
N-803EXPERIMENTALParticipants receive N-803 subcutaneously (SubQ) administered on day 1 of each 21-day cycle for up to 6 cycles.
Interventions
NameTypeDescription
N803DRUGN-803 subcutaneously (SubQ) administered on day 1 of each 21-day cycle for up to 6 cycles.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subjects aged ≥ 18 years. * Subjects with histologically confirmed B-cell NHL who have received commercially approved CD19-directed CAR T-cell therapy per FDA label * Subjects achieving CR or PR per Lugano Criteria to CAR T-cell therapy on D+30 post-CAR-T. * ECOG Performance S...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07049432studyFirstPostDate: changed