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CAR T-cell Therapy

CIML NK Cell Therapy for Acute Myeloid Leukemia

Phase 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

At least 18 years of age

Refractory AML without complete remission after 2 or more cycles of induction therapy or relapsed AML after obtaining a CR and failed re-induction therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year post transplantation

Awards & highlights

Study Summary

This trial is a study to improve leukemia survival rates in high-risk patients. Every six patients enrolled will have a safety evaluation, and the trial will be stopped if it is unusually dangerous.

Who is the study for?

Adults with Acute Myeloid Leukemia who haven't responded to at least two cycles of induction therapy or have relapsed after remission. Participants need a matched donor, good overall health, and normal organ function. They must use effective contraception and not be pregnant or breastfeeding.Check my eligibility

What is being tested?

The trial is testing the effectiveness of Memory-like Natural Killer (NK) cell therapy following a half-matched bone marrow transplant in high-risk leukemia patients. It aims to improve survival rates by using a combination of treatments including graft cell infusion, immune suppressants, growth factors, and NK cells.See study design

What are the potential side effects?

Potential side effects include reactions from infusions such as fever or chills; suppression of bone marrow leading to low blood counts; increased risk for infections due to immune suppressants; liver dysfunction; breathing difficulties; heart issues like reduced ejection fraction.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My AML did not respond to 2+ induction therapies or has returned after a complete remission.

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I have a donor who is a partial genetic match for me.

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

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I am not taking corticosteroids or immune suppressive medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year post transplantation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year post transplantation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post transplantation for reporting.

Treatment Details

Study Objectives

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

Secondary outcome measures

Incidence of relapse in patients who are found to be CR (complete remission)

Leukemia

Rate of overall survival (OS)

Side effects data

From 2017 Phase 2 trial • 20 Patients • NCT01097057

10%

Hyperglycemia

Febrile Neutropenia

DVT

Cellulitis

Atrial Fibrillation

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)

Trial Design

2Treatment groups

Experimental Treatment

Group I: RecipientExperimental Treatment6 Interventions

Standard of care reduced conditioning regimen on Day -1 Graft cell infusion on Day 0 Post-transplant cyclophosphamide on Days +3 and +4 GvHD prophylaxis with tacrolimus and mycophenolate mofetil (MMF) will start on Day +5. MMF will continue till Day +35 and tacrolimus till Day +180 in the absence of GvHD G-CSF will start on Day +7 and will continue until neutrophil engraftment as per institutional guidelines The cytokine-induced memory like natural killer (CIML NK) cells will be infused on Day +7 without a filter or pump, slowly by gravity over at least 15 minutes. ALT-803 will start approximately 4 hours after the CIML NK cell infusion. ALT-803 will be administered subcutaneously at a dose of 10 mcg/kg subcutaneously beginning Day +7 (on the day of CIML NK cell infusion) and then every 21 days for a total of 4 doses

Group II: DonorExperimental Treatment1 Intervention

Donors will receive subcutaneous G-CSF from Day -4 till Day 0 and undergo 20L apheresis per institutional guidelines. Two consecutive days for collection are allowed in case of the target CD34+ cell dose being less than the target 4 x106/kg-bw from the first day of collection. On Day +6 (one day before the planned CIML NK cell infusion), peripheral blood mononuclear cells will be collected by a single standard 20-L apheresis over 4-5 hours from the same haploidentical related donor that provided the HCT graft.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tacrolimus

2011

Completed Phase 4

~4740

Mycophenolate mofetil

2014

Completed Phase 4

~2350

G-CSF

2014

Completed Phase 4

~1610

ALT-803

2016

Completed Phase 2

~170

Leukapheresis

2016

Completed Phase 2

~690

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

ImmunityBio, Inc.Industry Sponsor

63 Previous Clinical Trials

5,076 Total Patients Enrolled

Washington University School of MedicineLead Sponsor

1,937 Previous Clinical Trials

2,299,642 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,790 Total Patients Enrolled

Media Library

Cytokine Induced Memory-like NK Cell Adoptive Therapy (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02782546 — Phase 2

Acute Myeloid Leukemia Research Study Groups: Recipient, Donor

Acute Myeloid Leukemia Clinical Trial 2023: Cytokine Induced Memory-like NK Cell Adoptive Therapy Highlights & Side Effects. Trial Name: NCT02782546 — Phase 2

Cytokine Induced Memory-like NK Cell Adoptive Therapy (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02782546 — Phase 2

Frequently Asked Questions

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

What medical applications is Leukapheresis generally employed to manage?

"Leukapheresis is a method used to treat several medical conditions, such as dermatitis atopic, acute myelocytic leukemia and kidney transplant rejection."

Answered by AI

How many participants have joined this experiment?

"Affirmative. According to the clinicaltrials.gov, this medical trial commenced on January 30th 2017 and has been recently modified in August 8th 2022. Sixty participants are currently sought from a single research facility."

Answered by AI

What potential adverse effects could arise from Leukapheresis treatments?

"Leukapheresis is a relatively new medical intervention, so its safety has been evaluated at a score of 2 due to the lack of efficacy data available from Phase 2 trials."

Answered by AI

Is enrollment in this clinical trial still open?

"The trial, initially published on January 30th 2017 and recently revised on August 8th 2022, is currently accepting volunteers. This information can be found through clinicaltrials.gov."

Answered by AI

Are there any precedents of Leukapheresis being utilized in research contexts?

"At this moment, 365 clinical trials investigating leukapheresis are ongoing; 67 of those are at Phase 3. This research is largely concentrated in Philadelphia, Pennsylvania but there exist 6430 trial centres scattered across the country conducting these studies."

Answered by AI

Recent research and studies

Science Translational MedicineJournal

Hematopoietic Cell Transplantation Donor-derived Memory-like NK Cells Functionally Persist After Transfer into Patients with Leukemia

Berrien-Elliott, Melissa M., Jennifer A. Foltz, David A. Russler-Germain, Carly C. Neal, Jennifer Tran, Margery Gang, Pamela Wong, et al.. 2022. “Hematopoietic Cell Transplantation Donor-derived Memory-like NK Cells Functionally Persist After Transfer into Patients with Leukemia”. Science Translational Medicine. American Association for the Advancement of Science (AAAS). doi:10.1126/scitranslmed.abm1375.

clinicaltrials.govStudy

Cytokine Induced Memory-like NK Cell Adoptive Therapy After Haploidentical Donor Hematopoietic Cell Transplantation

2017. "Cytokine Induced Memory-like NK Cell Adoptive Therapy After Haploidentical Donor Hematopoietic Cell Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02782546.

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