Membrane-bound Interleukin-21-Expanded Haploidentical Natural Killer Cells for Myelodysplastic Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Ohio State University Comprehensive Cancer Center, Columbus, OHMyelodysplastic Syndrome+4 MoreMembrane-bound Interleukin-21-Expanded Haploidentical Natural Killer Cells - Biological
Eligibility
18 - 80
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing donor natural killer cells as a treatment for leukemia. The goal is to find out if it is safe and if it has any side effects.

Eligible Conditions
  • Myelodysplastic Syndrome
  • Acute Recurrent Myeloid Leukemia
  • Bone Marrow Blast 10% or Higher
  • Allogeneic Stem Cell Transplant Recipient
  • Refractory Acute Myelogenous Leukemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: Up to 63 days

Up to 63 days
Maximum tolerated dose (MTD) of membrane-bound interleukin-21-expanded haploidentical natural killer (NK) cells
Up to day 28
Incidence of adverse events
Up to day 56
CR with incomplete hematologic recovery
Chimerism analysis to determine origin and number of circulating NK cells
Complete response (CR)
Identification of In-vivo expansion of NK cells
Incidence of infectious complications
Median duration of remission
Median relapse free survival
Median time to neutrophil and platelet count recovery
Morphologic leukemia-free state
Number of donor human leukocyte antigen (HLA) detection
Percentage of patients receiving the regimen who are rendered transplant-eligible

Trial Safety

Trial Design

4 Treatment Groups

Cohort II (fludarabine, decitabine, NK cell therapy)
1 of 4
Induction
1 of 4
Cohort I (fludarabine, cytarabine, NK cell therapy)
1 of 4
Conditioning Regimen
1 of 4

Experimental Treatment

30 Total Participants · 4 Treatment Groups

Primary Treatment: Membrane-bound Interleukin-21-Expanded Haploidentical Natural Killer Cells · No Placebo Group · Phase 1

Cohort II (fludarabine, decitabine, NK cell therapy)Experimental Group · 4 Interventions: Decitabine, Fludarabine Phosphate, Fludarabine, Membrane-bound Interleukin-21-Expanded Haploidentical Natural Killer Cells · Intervention Types: Drug, Drug, Drug, Biological
Induction
Biological
Experimental Group · 1 Intervention: Membrane-bound Interleukin-21-Expanded Haploidentical Natural Killer Cells · Intervention Types: Biological
Cohort I (fludarabine, cytarabine, NK cell therapy)Experimental Group · 5 Interventions: Cytarabine, Fludarabine Phosphate, Cytarabine Hydrochloride, Fludarabine, Membrane-bound Interleukin-21-Expanded Haploidentical Natural Killer Cells · Intervention Types: Drug, Drug, Drug, Drug, Biological
Conditioning RegimenExperimental Group · 2 Interventions: Cytarabine Hydrochloride, Fludarabine · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
FDA approved
Decitabine
FDA approved
Fludarabine
FDA approved
Fludarabine
FDA approved
Natural Killer Cell
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 63 days

Who is running the clinical trial?

Sumithira VasuLead Sponsor
4 Previous Clinical Trials
58 Total Patients Enrolled
Sumithira Vasu, MBBS4.36 ReviewsPrincipal Investigator - Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
3 Previous Clinical Trials
22 Total Patients Enrolled
5Patient Review
Dr. Vasu is an excellent hematologist/transplant physician who is extremely skilled and knowledgeable. But more importantly, she cares deeply for her patients.

Eligibility Criteria

Age 18 - 80 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

Is it feasible for individuals to join this clinical trial?

"Indications from clinicaltrials.gov suggest that this medical experiment is still open to applicants, with the initial advertisement dated June 1st 2020 and most recent updates published on February 7th 2022." - Anonymous Online Contributor

Unverified Answer

To what illnesses is Membrane-bound Interleukin-21-Expanded Haploidentical Natural Killer Cells commonly applied?

"Membrane-bound Interleukin-21-Expanded Haploidentical Natural Killer Cells has been proven to be a viable treatment for individuals in intermediate 2 risk category of ipss, who are afflicted with refractory anemias or blast phase chronic myelocytic leukemia." - Anonymous Online Contributor

Unverified Answer

Is it feasible for me to participate in this medical study?

"This clinical trial is selecting up to 30 patients who suffer from a certain syndrome and are over 18 years old, but under 80." - Anonymous Online Contributor

Unverified Answer

What does this clinical investigation aspire to discover?

"This trial, which will span 28 days, seeks to determine the Maximum Tolerated Dosage of membrane-bound interleukin-21-expanded haploidentical natural killer (NK) cells. Descriptive statistics are used to measure secondary outcomes such as Median Time for Neutrophil and Platelet Count Recovery, Median Duration of Remission, and Percentage of Patients Rendered Transplant Eligible by this Regimen." - Anonymous Online Contributor

Unverified Answer

What evidence exists to suggest that Membrane-bound Interleukin-21-Expanded Haploidentical Natural Killer Cells have been successfully tested in the past?

"Currently, there are 677 studies examining the efficacy of Membrane-bound Interleukin-21-Expanded Haploidentical Natural Killer Cells with 82 trials in their final testing phase. Grand Rapids is hosting a significant number of these assessments however, 13389 medical centers globally offer this treatment." - Anonymous Online Contributor

Unverified Answer

Is this research study offering enrollment to those over thirty years of age?

"This clinical trial is searching for participants of age 18 years or older, but less than 80." - Anonymous Online Contributor

Unverified Answer

What is the scope of this research project in terms of participants?

"Indeed, according to the information located on clinicaltrials.gov, this medical experiment is currently recruiting individuals for participation. Its initial posting date was June 1st 2020 and it has been updated most recently on February 7th 2022. This study requires 30 volunteers from a single site." - Anonymous Online Contributor

Unverified Answer

Could you elucidate any health risks associated with Membrane-bound Interleukin-21-Expanded Haploidentical Natural Killer Cells treatment?

"As this is a Phase 1 trial with limited safety and efficacy data, our team at Power has assessed the safety of Membrane-bound Interleukin-21-Expanded Haploidentical Natural Killer Cells to be an estimated score of 1." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.