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Neukoplast

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment7

FDA Designations

No designations recorded

Clinical trial landscape

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 an investigational monoclonal antibody being studied for the treatment of acute myeloid leukemia (AML). It is being developed for patients with refractory or relapsed AML, meaning the disease has not responded to prior treatment or has returned after an initial response.

Who makes Neukoplast?

Neukoplast 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 safety and efficacy of this investigational therapy in patients with acute myeloid leukemia.

What phase is Neukoplast in?

Neukoplast is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being evaluated in clinical trials. The Phase 1 trial for Neukoplast has been completed, and it is not currently listed as an active trial.

What clinical trials is Neukoplast in?

Neukoplast has been studied in one clinical trial, identified as NCT00900809, titled 'QUILT-3.018: Neukoplast™ (NK-92) for the Treatment of Refractory or Relapsed Acute Myeloid Leukemia.' This was a Phase 1, uncontrolled trial conducted in the United States with 7 enrolled participants aged 18 years and older. The trial has been completed.

Is Neukoplast the same as NK-92?

Yes, Neukoplast is also known as NK-92. The clinical trial NCT00900809 refers to Neukoplast as 'NK-92' in its title, indicating that these names refer to the same investigational therapy being developed for acute myeloid leukemia.