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CAR T-cell Therapy

CIML NK Cells for Leukemia

Phase 1

Waitlist Available

Led By Rizwan Romee, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate organ function within 2 weeks of NK cell infusion as defined below: Total bilirubin: ≤1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then <3 x ULN) AST(SGOT)/ALT(SGPT): ≤3 x institutional ULN Serum creatinine ≤2.0mg/dL O2 saturation: ≥90% on room air LVEF >40%. If there is no clinical evidence of a change in cardiovascular function from the time of pre-transplantation ECHO, then there is no need to repeat it. Otherwise, an ECHO will need to be repeated within 2 weeks of NK cell infusion.

ECOG performance status ≤2. For patients in the pediatric cohort, this corresponds to a Lansky (patients <16 years) or Karnofsky (≥16years) performance status of ≥50.

Must not have

Prior history of severe (grade 3 or 4) acute GVHD, or ongoing active GVHD requiring systemic treatment.

Individuals with active uncontrolled hepatitis B or C, HIV, or HTLV-1 are ineligible as they are at high risk of lethal treatment-related hepatotoxicity after HSCT.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying CIML NK cells plus IL-2 in treating patients with acute myeloid leukemia, myelodysplastic syndrome, or myeloproliferative neoplasms who have relapsed after stem cell transplantation.

Who is the study for?

Adults and children (12+) with certain relapsed myeloid diseases after stem cell transplant can join. They need a willing original donor for cell collection, no recent severe GVHD treatments, and must use birth control. Excluded are those with autoimmune disease, active infections like hepatitis or HIV, recent other cancer treatments outside of specific exceptions, or uncontrolled illnesses.

What is being tested?

The trial is testing CIML NK cells combined with IL-2 in patients who have had a relapse of AML, MDS or MPN after stem cell transplantation. It will evaluate the safety and effectiveness of this treatment approach in both adult and pediatric patients.

What are the potential side effects?

Potential side effects may include reactions to the infusion such as fever or chills, organ inflammation due to immune response from IL-2 therapy, increased risk of infection from Fludarabine/Cyclophosphamide chemotherapy regimen used before NK cell infusion.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself and do some daily activities.

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I haven't taken high-dose steroids or certain immune system drugs for 4 weeks.

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

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I am 12 years old or older.

Exclusion Criteria

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

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I have had severe graft-versus-host disease or it's currently active and needs treatment.

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I do not have active, uncontrolled hepatitis B or C, HIV, or HTLV-1.

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I am not HIV-positive.

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I am not pregnant or breastfeeding.

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I do not have any serious illnesses that could interfere with the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

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

Treatment Details

Study Objectives

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

Primary study objectives

Safety

Secondary study objectives

Acute GVHD (Incidence, Severity)

Chronic GVHD (Incidence, Severity)

LFS and OS

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: CIML NKExperimental Treatment3 Interventions

* CIML NK cells will be administered intravenously on day 0. * Fludarabine will be administered as IV infusion once daily for 3 doses beginning on day -5. * Cyclophosphamide will be administered as IV infusion on days -5 and -4.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 4

~1860

Cyclophosphamide

2010

Completed Phase 4

~2310