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Cell Therapy

Memory-like NK Cell Therapy for Acute Myeloid Leukemia

Phase 1 & 2

Recruiting

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

Adequate organ function as defined below: Total bilirubin < 2 mg/dL, AST(SGOT)/ALT(SGPT) < 3.0 x IULN, Creatinine within normal institutional limits OR creatinine clearance > 60 mL/min/1.73 m2 by Cockcroft-Gault Formula, Oxygen saturation ≥90% on room air, Not currently requiring systemic corticosteroid therapy (10 mg or less of prednisone or equivalent doses of other systemic steroids are allowed) or any other immune suppressive medications, Women of childbearing potential must have a negative pregnancy test within 28 days prior to study registration. Female and male patients (along with their female partners) must agree to use two forms of acceptable contraception, including one barrier method, during participation in the study including throughout the initial evaluation period (100 days after CIML NK cell infusion), Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable)

Available original donor (same donor as used for the initial stem cell transplant) that is willing and eligible for non-mobilized collection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year post ciml nk cell infusion

Awards & highlights

Study Summary

This trial is testing whether combining CIML NK cells with DLI will help patients with leukemia who have relapsed after allo-HCT.

Who is the study for?

This trial is for adults who have relapsed Acute Myeloid Leukemia after a stem cell transplant from a matched donor. They must be in good health, with normal organ function and no active infections or uncontrolled heart conditions. Pregnant women or those on systemic steroids/high blast counts are excluded.Check my eligibility

What is being tested?

The study tests combining Cytokine Induced Memory-like Natural Killer (CIML NK) cells with Donor Lymphocyte Infusion (DLI) to improve treatment outcomes in relapsed AML patients post-transplant. It aims to enhance graft versus leukemia effects without excessive Graft versus Host Disease.See study design

What are the potential side effects?

Potential side effects may include reactions related to immune activation such as fever, fatigue, and risk of infection. There's also the possibility of developing mild to severe Graft versus Host Disease due to immune system interactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My original stem cell donor is available and willing to donate again without mobilization.

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I can care for myself but may not be able to do active work.

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My AML has returned after a bone marrow transplant from a matched donor.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year post ciml nk cell infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year post ciml nk cell infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post ciml nk cell infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility of regimen defined as the number of participants who are successfully infused with T cell DLT and CIML NK cells (Pilot Pediatric/Young Adult Cohort)

Safety of administering CIML NK cells plus T cell DLT as measured by prolonged neutropenia (Phase 2 Adult Cohort)

Safety of administering CIML NK cells plus T cell DLT as measured by prolonged neutropenia (Pilot Pediatric/Young Adult Cohort)

+4 more

Secondary outcome measures

Complete remission rate (CR/CRi) (Phase 2 Adult Cohort)

Complete remission rate (CR/CRi) (Pilot Pediatric/Young Adult Cohort)

Incidence and severity of acute GVHD rates (Phase 2 Adult Cohort)

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: CIML NK cell after T cell DLT (Pilot Pediatric/Young Adult Cohort)Experimental Treatment2 Interventions

The recipient will receive standard of care salvage chemotherapy consisting of fludarabine (or cladribine if shortage), cytarabine, and G-CSF (FLAG) to be started 2 to 4 weeks prior to the CIML NK cell infusion. 5-day decitabine is an acceptable alternative for FLAG, and another standard of care salvage chemotherapy regimen, if clinically appropriate and approved by the study PI, may be used. The donor will undergo non-mobilized leukapheresis on Day -2 or -1. Standard of care DLI (1 x 10^6 CD3+ cells/kg) will be given fresh on day -1. A second cycle of therapy may be administered > 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.

Group II: CIML NK cell after T cell DLT (Phase 2 Adult Cohort)Experimental Treatment2 Interventions

The recipient will receive lymphodepleting chemotherapy with fludarabine (or cladribine if shortage) and cyclophosphamide beginning on day -7. The donor will undergo non-mobilized leukapheresis on Day -2 or -1. T cell dose per standard of care institutional practices and physician discretion will be given frozen for administration on day 30. A second cycle of therapy may be administered > 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the second NK cell infusion will be considered a second Day 0.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,936 Previous Clinical Trials

2,299,742 Total Patients Enrolled

Amanda Cashen, M.D.Principal InvestigatorWashington University School of Medicine

7 Previous Clinical Trials

275 Total Patients Enrolled

Media Library

Cytokine Induced Memory-like NK Cell Adoptive Therapy (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03068819 — Phase 1 & 2

Acute Myeloid Leukemia Research Study Groups: CIML NK cell after T cell DLT (Pilot Pediatric/Young Adult Cohort), CIML NK cell after T cell DLT (Phase 2 Adult Cohort)

Acute Myeloid Leukemia Clinical Trial 2023: Cytokine Induced Memory-like NK Cell Adoptive Therapy Highlights & Side Effects. Trial Name: NCT03068819 — Phase 1 & 2

Cytokine Induced Memory-like NK Cell Adoptive Therapy (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03068819 — Phase 1 & 2

Frequently Asked Questions

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

What is the desired outcome of this research?

"The primary goal of this clinical trial, which will last for up to 12 months, is to assess the feasibility of the regimen. This is defined as the number of participants who are able to successfully receive T cell DLT and CIML NK cells. Secondary outcomes include the complete remission rate (CR/CRi) and leukemia-free survival (LFS) rate. The CR/CRi is defined as a morphologically leukemia-free state where there are no blasts with Auer rods and no extramedullary leukemia. To meet the criteria for CR/CRi, patients must also have an absolute neutrophil count"

Answered by AI

Are there any available openings for participants in this research project?

"Yes, the online information indicates that this study is still looking for volunteers. The trial was first posted on October 23rd, 2017 and updated less than a week ago onOctober 26th, 2020."

Answered by AI

How many people are allowed to sign up for this research project?

"That is correct. The clinical trial in question, which was initially posted on October 23rd 2017 and updated most recently on October 26th 2022, is still recruiting patients. 110 individuals are needed to participate across 1 location."

Answered by AI

Recent research and studies

BloodJournal

Donor Memory-like NK Cells Persist and Induce Remissions in Pediatric Patients with Relapsed AML After Transplant

Bednarski, Jeffrey J., Clare Zimmerman, Melissa M. Berrien-Elliott, Jennifer A. Foltz, Michelle Becker-Hapak, Carly C. Neal, Mark Foster, et al.. 2022. “Donor Memory-like NK Cells Persist and Induce Remissions in Pediatric Patients with Relapsed AML After Transplant”. Blood. American Society of Hematology. doi:10.1182/blood.2021013972.

BloodJournal

Donor Memory-like NK Cells Persist and Induce Remissions in Pediatric Patients with Relapsed AML After Transplant

clinicaltrials.govStudy

Cytokine Induced Memory-like NK Cell Adoptive Therapy for Relapsed AML After Allogeneic Hematopoietic Cell Transplant

2017. "Cytokine Induced Memory-like NK Cell Adoptive Therapy for Relapsed AML After Allogeneic Hematopoietic Cell Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03068819.

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