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haNK for Infusion

Phase 1

Solid Tumor | Monoclonal antibody | Oncology |ImmunityBio, Inc.|Last Updated: Nov 20, 2024

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 Enrollment6
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03027128QUILT-3.028: Study of haNK™ for Infusion in Subjects With Metastatic or Locally Advanced Solid TumorsPHASE1 COMPLETED 6Aug 2, 2017May 6, 2019Nov 20, 20241 United States
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Study Endpoints
Primary Endpoints
Determination of Maximum Tolerated Dose (MTD) or Highest Tested Dose (HTD).
28 days/4 weeks
Occurrence of Dose-limiting Toxicities (DLTs).
28 days/4 weeks
Number of Participants With Treatment-emergent Adverse Event (AEs) and Serious Adverse Events (SAEs)
The investigator will record all reportable events with start dates occurring any time after informed consent is obtained until 30 days after the last day of study participation, up to 5.3 months.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1, 2x10^9 Cells haNK™EXPERIMENTALNK-92 \[CD16.158V, ER IL-2\], Suspension for Intravenous Infusion
Interventions
NameTypeDescription
haNK™ for InfusionBIOLOGICALhaNK™ for Infusion is a human, allogeneic, NK cell line that has been engineered to produce endogenous, intracellularly retained IL-2 and to express CD16, the high-affinity (158V) Fc gamma receptor (FcγRIIIa/CD16a).
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Age ≥ 18 years old. 2. Able to understand and provide a signed informed consent that fulfills the relevant IRB or IEC guidelines. 3. Histologically confirmed, unresectable, locally advanced or metastatic solid malignancy. 4. ECOG performance status of 0 to 2. 5. Have at least...

Countries:United States
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