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haNK for Infusion

Phase 1

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

haNK for Infusion development status

Highest phase Phase 1
Registered trials 6 across 1 sponsor since Nov 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

haNK for Infusion clinical trials

haNK for Infusion · 1 trial · 1 indication

Phase 1 1
NCT03027128QUILT-3.028: Study of haNK™ for Infusion in Subjects With Metastatic or Locally Advanced Solid TumorsSolid Tumor
COMPLETED6 Analytics
PHASE1COMPLETED
QUILT-3.028: Study of haNK™ for Infusion in Subjects With Metastatic or Locally Advanced Solid Tumors
Solid TumorUnlock trial analytics

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 to 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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Competitive Landscape -Other Solid Tumors 10 trials (matched to "Solid Tumor")

Frequently asked questions about haNK for Infusion

What is haNK for Infusion?

haNK for Infusion is an investigational cell-based immunotherapy being studied in solid tumors. It is developed by ImmunityBio, Inc. (ticker IBRX) and has been evaluated in a Phase 1 clinical trial in patients with metastatic or locally advanced solid tumors. It is not an approved therapy and remains in clinical development.

What is haNK for Infusion used for?

haNK for Infusion has been studied for the treatment of metastatic or locally advanced solid tumors. The Phase 1 trial enrolled adults 18 years and older with these advanced solid tumor types. It is an investigational agent and has not been approved for any indication.

Who makes haNK for Infusion?

haNK for Infusion is developed by ImmunityBio, Inc., which trades under the ticker IBRX. The company sponsored the Phase 1 study of the agent in patients with metastatic or locally advanced solid tumors in the United States.

What phase is haNK for Infusion in?

haNK for Infusion is in Phase 1 development. It has been evaluated in a single Phase 1 trial, which is now completed, enrolling 6 participants with metastatic or locally advanced solid tumors. It is investigational and has not received FDA approval.

What clinical trials is haNK for Infusion in?

haNK for Infusion has been studied in one clinical trial, NCT03027128, titled QUILT-3.028: Study of haNK for Infusion in Subjects With Metastatic or Locally Advanced Solid Tumors. The Phase 1 trial was conducted in the United States, enrolled 6 participants, and is completed.

Is haNK for Infusion the same as haNK?

Yes, haNK for Infusion and haNK refer to the same investigational product. The full name is sometimes written as haNK for Infusion, and the trademarked form haNK™ for Infusion is also used. Both names refer to the ImmunityBio, Inc. (IBRX) agent studied in solid tumors.