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NK Cell Therapy

IL-21 Expanded Natural Killer Cells for Leukemia

Phase 1
Recruiting
Led By Sumithira Vasu, MBBS
Research Sponsored by Sumithira Vasu
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 up to 63 days
Awards & highlights

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.

Who is the study for?
This trial is for adults with recurrent or treatment-resistant acute myeloid leukemia (AML) who weigh at least 42 kg, have a decent heart function and performance status, controlled seizures if present, acceptable liver and kidney functions, no active graft-versus-host disease or uncontrolled infections. They must not be on high-dose steroids or have had recent investigational therapies.Check my eligibility
What is being tested?
The trial is testing the safety of donor natural killer (NK) cells that are expanded using membrane-bound Interleukin-21 to treat AML. These genetically modified NK cells may help the immune system stop cancer growth and spread.See study design
What are the potential side effects?
Potential side effects include reactions related to immune response such as inflammation in various organs, infusion-related reactions from the cell therapy itself, and complications due to underlying conditions being exacerbated by treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 63 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 63 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Maximum tolerated dose (MTD) of membrane-bound interleukin-21-expanded haploidentical natural killer (NK) cells
Secondary outcome measures
CR with incomplete hematologic recovery
Complete response (CR)
Incidence of infectious complications
+5 more
Other outcome measures
Chimerism analysis to determine origin and number of circulating NK cells
Identification of In-vivo expansion of NK cells
Number of donor human leukocyte antigen (HLA) detection

Trial Design

2Treatment groups
Experimental Treatment
Group I: InductionExperimental Treatment1 Intervention
Six doses of third-party-donor mbIL-21 expanded (KDS-1001) cells given thrice weekly for two weeks. Days may vary and KDS-1001 can be given from days 0 to 21
Group II: Conditioning RegimenExperimental Treatment2 Interventions
Fludarabine 30 mg/m2/day (day -6 to day -2) and Cytarabine 2g/ m2/day (days -6 to day -2)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1100
Membrane-bound Interleukin-21-Expanded Haploidentical Natural Killer Cells
2014
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Kiadis PharmaIndustry Sponsor
11 Previous Clinical Trials
533 Total Patients Enrolled
Sumithira VasuLead Sponsor
5 Previous Clinical Trials
101 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
32 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.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Trial Testing Safety of IL-21 NK Cells for Induction of R/R AML
Sumithira Vasu 2020. "Trial Testing Safety of IL-21 NK Cells for Induction of R/R AML". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04220684.
~4 spots leftby Apr 2025
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