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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

Must not have

Uncontrolled bacterial or viral infections, known HIV, Hepatitis B or C infection

Relapsed after allogeneic transplantation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year post transplantation

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any uncontrolled infections or known HIV, Hepatitis B or C.

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My condition worsened after a transplant from another person.

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I have new lung issues that haven't been checked with a lung scope.

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I do not have uncontrolled heart problems.

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I have high levels of specific antibodies in my blood.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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

Leukemia

Rate of overall survival (OS)

Side effects data

From 2023 Phase 1 & 2 trial • 5 Patients • NCT03318900

100%

Abdominal distension

100%

Anemia

50%

White blood cell decreased

50%

Dizziness

50%

Hypotension

50%

Fatigue

50%

Urine output decreased

100%

80%

60%

40%

20%

Study treatment Arm

Dose Level 2

Dose Level 3

Dose Level 1

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2019

Completed Phase 4

~5510

Mycophenolate mofetil

2014

Completed Phase 4

~3060