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Cytokine-induced Memory-like NK Cells in Relapsed/Refractory AML and MDS

NCT04893915 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-03-11

No results posted yet for this study

Summary

Patients with relapsed/refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) will receive lymphodepleting chemotherapy (Flu/Cy) and two infusions of cytokine-induced memory-like NK cells at the previously defined maximum tolerated dose (MTD), fourteen days apart. Low dose rhIL-2 will be administered to patients for in vivo expansion following cell infusion. Patients will be assessed for anti-leukemic efficacy and safety. Re-infusion of patients who relapsed after clinical response will be considered.

Conditions

Interventions

BIOLOGICAL

Cytokine-induced memory-like NK cells

Cell product processing is performed at the Siteman Cancer Center Biological Therapy Core or another FACT-accredited cellular therapy production facility that can manufacture the product per the IND CMC.

DRUG

Fludarabine

-Lymphodepleting regimen

DRUG

Cyclophosphamide

-Lymphodepleting regimen

PROCEDURE

Donor Leukapheresis

-Apheresis will be performed via peripheral IVs or central line, as determined by the apheresis team.

DRUG

Interleukin-2

-IL-2 will start approximately 2-4 hours after the NK cell infusions.

Sponsors & Collaborators

  • Wugen, Inc.

    collaborator INDUSTRY

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Amanda Cashen, M.D. · Washington University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Drug
Yes

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04893915 on ClinicalTrials.gov