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Chemotherapy

Cytokine-induced memory-like NK cells for Myelodysplastic Syndrome

Phase 2
Waitlist Available
Led By Amanda Cashen, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 12 month follow-up
Awards & highlights

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.

Eligible Conditions
  • Myelodysplastic Syndrome
  • Acute Myelogenous Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 12 month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and through 12 month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall response rate (ORR) of recipients
Secondary study objectives
Change in quality of life experienced by recipients as measured by the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ-C30)
Duration of complete response (DoCR) of recipients
Duration of overall response (DOR) of recipients
+9 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Phase II Recipient: Cytokine-induced memory-like NK cellsExperimental Treatment4 Interventions
* Fludarabine and cyclophosphamide beginning on Day -6. * NK cell product will be infused on Day 0. * IL-2 will begin 2-4 hours after infusion and will continue every other day through Day 12 for a total of 7 doses. * NK cell product will be infused into the recipient on Day +14. * IL-2 will begin 2-4 hours after infusion and will continue every other day through Day 26 for an additional 7 doses, and a total of 14 doses, to a maximum of two vials of rhIL-2 per IL-2 course. * Will receive the NK cell product on Day 0 and Day +14, receiving the maximum NK cells generated, capped at 20x10\^6/kg. * Patients that have an initial response but then subsequently relapse or progress will be able to receive a third dose of NK cell product with or without lymphodepleting chemotherapy depending on the interval duration between the second dose and relapse, after approval by the study PI. The third dose should be administered not less than 45 days from Day 0.
Group II: Lead In Cohort Recipient: Cytokine-induced memory-like NK cellsExperimental Treatment4 Interventions
* Fludarabine and cyclophosphamide beginning on Day -6. * NK cell product will be infused on Day 0. * IL-2 will begin 2-4 hours after infusion and will continue every other day through Day 12 for a total of 7 doses. * NK cell product will be infused into the recipient on Day +14. * IL-2 will begin 2-4 hours after infusion and will continue every other day through Day 26 for an additional 7 doses, and a total of 14 doses, to a maximum of two vials of rhIL-2 per IL-2 course. * In the Lead-in Cohort, three patients will receive NK cell product on Day 0 and Day +14, receiving the maximum NK cells generated, capped at 20x10\^6/kg. * Patients that have an initial response but then subsequently relapse or progress will be able to receive a third dose of NK cell product with or without lymphodepleting chemotherapy depending on the interval duration between the second dose and relapse, after approval by the study PI. The third dose should be administered not less than 45 days from Day 0.
Group III: DonorExperimental Treatment1 Intervention
* The allogeneic donor will undergo non-mobilized large volume (20-L) leukapheresis on Day -1. * On Day +13 the allogeneic donor will again undergo non-mobilized large volume (20-L) leukapheresis
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1020
Cyclophosphamide
1995
Completed Phase 3
~3770
Interleukin-2
1994
Completed Phase 3
~690

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,970 Previous Clinical Trials
2,309,319 Total Patients Enrolled
Wugen, Inc.Industry Sponsor
6 Previous Clinical Trials
306 Total Patients Enrolled
Amanda Cashen, M.D.Principal InvestigatorWashington University School of Medicine
7 Previous Clinical Trials
385 Total Patients Enrolled
~0 spots leftby Dec 2024
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