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CD19 t-haNK- Administration

Phase 2

Relapsed B-Cell Non-Hodgkin Lymphoma | Monoclonal antibody | Oncology |ImmunityBio, Inc.|Last Updated: Mar 17, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07477366Study of CD19 t-haNK and NAI With Rituximab in Participants With Indolent Non-Hodgkin LymphomaPHASE2 NOT YET_RECRUITING 20Apr 1, 2026Dec 1, 2028Mar 17, 2026 -
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Study Endpoints
Primary Endpoints
ORR in accordance with Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC)
Up to 9 months
OS (time from study treatment initiation to death)
Up to 89 weeks
Secondary Endpoints
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) graded using the National Cancer Institute (NCI) CTCAE Version 6.0
Up to 37 weeks
Clinically important changes in laboratory tests - Hematology
Up to 37 weeks
Clinically important changes in laboratory tests - Chemistry
Up to 37 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Open Label- Single ArmOTHEROpen label: combination of Rituximab and investigational products
Interventions
NameTypeDescription
CD19 t-haNK- IV AdministrationBIOLOGICALCD19-Directed Therapies: CD19-targeted therapies, are biologic agents specifically designed to recognize and eliminate CD19-expressing B-cell malignancies. These therapies differ from traditional chemotherapy or small molecule inhibitors by leveraging the patient's immune system to achieve targeted cytotoxicity. Their mechanism of action involves direct binding to the CD19 antigen on malignant B cells, leading to immune-mediated cell death.
N-803DRUGN-803 Subcutaneous (SQ): N-803 is a novel IL-15 superagonist immunotherapy administered subcutaneously. It is designed to enhance the proliferation and activation of natural killer (NK) cells and CD8+ T cells without stimulating regulatory T cells. N-803 SQ differs from other cytokine therapies due to its improved pharmacokinetic profile, enhanced in vivo activity, and reduced toxicity.
rituximabDRUGRituximab is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Rituximab has an approximate molecular weight of 145 kD and has a binding affinity for the CD20 antigen of approximately 8.0 nM.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: 1. Age ≥ 18 to ≤ 75 years old. 2. Able to understand and provide a signed informed consent that fulfils the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines. 3. Histologically or flow cytometry documented relapsed/refractory B-cell indol...

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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07477366primaryCompletionDate: changed
LOWMay 24, 2026NCT07477366studyFirstPostDate: changed