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Phase 1 CIML NK Cell Infusion for Myeloid Disease Relapse After Transplant

This study is a Phase 1 clinical trial testing a new treatment called CIML NK cell infusion, combined with chemotherapy drugs Fludarabine and Cyclophosphamide, for people with certain blood cancers (Acute Myeloid Leukemia, Myelodysplastic Syndromes, Myeloproliferative Neoplasm, or Juvenile Myelomonocytic Leukemia) that have returned after a stem cell transplant. CIML NK cells are a type of immune cell that may be better at finding and killing cancer cells. The main goal is to see how safe this new treatment is. You may be able to join if you are 12 years or older and your cancer has relapsed or persisted after a transplant. The study plans to enroll 50 participants.

Study design
This is a Phase 1 interventional study, meaning it's an early-stage trial focused on safety and finding the right dose. It plans to enroll 50 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be measured at 6 weeks after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04024761

A Phase 1 Trial of CIML NK Cell Infusion for Myeloid Disease Relapse After Hematopoietic Cell Transplantation

Recruiting
PHASE1Ages 12+InterventionalTreatment
Dana-Farber Cancer Institute
~50 participants
Updated 2026-06-17 on ClinicalTrials.gov
What's tested:CIML NKFludarabineCyclophosphamide

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety
Measured over 6 Weeks

Conditions

Acute Myeloid Leukemia
Myelodysplastic Syndromes
Myeloproliferative Neoplasm
Juvenile Myelomonocytic Leukemia

Explore related trials

Acute Myeloid LeukemiaJuvenile Myelomonocytic LeukemiaMyelodysplastic SyndromeMyeloproliferative NeoplasmT cell chimerism

Where it's being run

2 sites across 1 states
Massachusetts2

Study leadership

  • Susanne Baumeister, MD · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute

Who to contact

Roman M. Shapiro, MD
[email protected]
617-632-3470
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

What this trial measures

  • Safety6 Weeks

    To determine the maximum tolerated dose (MTD) of CIML NK cell infusion followed by low-dose IL-2