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haNK for Infusion

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

Clinical trial landscape

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 9 trials (matched to "Solid Tumor")

Frequently asked questions about haNK for Infusion

What is haNK for Infusion used for?

haNK for Infusion is an investigational therapy being studied for the treatment of metastatic or locally advanced solid tumors. It is a monoclonal antibody-based treatment in clinical development for oncology indications.

Who is developing haNK for Infusion?

haNK for Infusion is being developed by ImmunityBio, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol IBRX. The company is conducting clinical research to evaluate the therapy in patients with solid tumors.

What phase is haNK for Infusion in?

haNK for Infusion is in Phase 1 clinical development. It is an investigational agent and has not been approved by regulatory authorities. The therapy is being evaluated for safety and tolerability in patients with advanced solid tumors.

What clinical trials is haNK for Infusion in?

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

What is the mechanism of action of haNK for Infusion?

haNK for Infusion is a monoclonal antibody-based therapy. It is designed to target and engage the immune system to fight cancer cells. The specific molecular target of haNK for Infusion has not been disclosed in available clinical trial information.