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Neukoplast

Phase 1

Acute Myeloid Leukemia | Monoclonal antibody | Oncology |ImmunityBio, Inc.|Trials Updated: Apr 5, 2022

Neukoplast target and mechanism

ModalityMonoclonal antibody

Also known as Neukoplast™ (NK-92)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment7

FDA Designations

No designations recorded

Neukoplast clinical trials

Neukoplast · 1 trial · 1 indication

Phase 1 1
NCT00900809QUILT-3.018: Neukoplast™ (NK-92) for the Treatment of Refractory or Relapsed Acute Myeloid LeukemiaAcute Myeloid Leukemia
COMPLETED7 Analytics
PHASE1COMPLETED
QUILT-3.018: Neukoplast™ (NK-92) for the Treatment of Refractory or Relapsed Acute Myeloid Leukemia
Acute Myeloid LeukemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Determine the safety / maximum tolerated dose of Neukoplast™ (NK-92 cell line for clinical use) in patients with refractory or relapsed acute myeloid leukemia
2016

Secondary Endpoints

Evaluate the therapeutic efficacy of Neukoplast™ in patients with refractory or relapsed acute myeloid leukemia
2016
Determine the Neukoplast™ cell phenotype and cytotoxic activity at different time intervals after the Neukoplast™ cell infusion
2016
Determine the presence of Neukoplast™ in the bone marrow
2016
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Neukoplast™ (NK-92)EXPERIMENTALNeukoplast™ will be infused in three doses.1 x 10e9 cells/m2 dose, 3 x 10e9 cells/m2 dose, 5 x 10e9 cells/m2 dose.

Interventions

NameTypeDescription
Neukoplast™ (NK-92)BIOLOGICALThe Neukoplast™ (NK-92) cells will be administered intravenously over 60 minutes. The starting dose of Neukoplast™ (NK-92) cells will be 1 x 10e9 ZRx-101 cells/m2 (The 3 dose levels are: 1 x 10e9 cells/m2, 3 x 10e9 cells/m2 and 5 x 10e9 cells/m2). The second infusion will only be administered after 24 hours if no unacceptable or dose limiting toxicities side effects due to the infusion of Neukoplast™ were encountered after the first infusion.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients with refractory/relapse acute myeloid leukemia. Patients must not have received radiotherapy, chemotherapy (with the exception of hydroxyurea which must be discontinued 72 hours prior to therapy) or biological therapy within the preceding 2 weeks of the planned first ...

Countries:United States
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Frequently asked questions about Neukoplast

What is Neukoplast used for?

Neukoplast is being studied for the treatment of refractory or relapsed acute myeloid leukemia (AML), a cancer of the blood and bone marrow. It is an investigational therapy, not an approved treatment, and has been evaluated in a single Phase 1 clinical trial in adults with AML.

Who is developing Neukoplast?

Neukoplast is being developed by ImmunityBio, Inc., a biopharmaceutical company whose common stock trades on the Nasdaq under the ticker symbol IBRX. ImmunityBio is the sponsor of the clinical program evaluating Neukoplast in acute myeloid leukemia.

What phase is Neukoplast in?

Neukoplast is in Phase 1 clinical development. It has been evaluated in one completed Phase 1 trial in patients with refractory or relapsed acute myeloid leukemia. It is investigational and has not been approved by the FDA for any indication.

What clinical trials is Neukoplast in?

Neukoplast has been studied in the Phase 1 trial NCT00900809, titled QUILT-3.018: Neukoplast (NK-92) for the Treatment of Refractory or Relapsed Acute Myeloid Leukemia. The trial enrolled 7 participants in the United States and is now completed.

Is Neukoplast the same as NK-92?

Yes, Neukoplast is also known as Neukoplast (NK-92). The NK-92 designation refers to the natural killer cell line from which the therapy is derived. Both names refer to the same investigational product being developed by ImmunityBio for acute myeloid leukemia.