What is CIML NK cell infusion studying for myeloid disease relapse after stem cell transplantation?

CIML NK cell infusion is being studied as a potential treatment for patients with myeloid diseases like AML, MDS, MPN, or JMML that return after stem cell transplant. Researchers aim to evaluate the safety and appropriate dosing of this investigational therapy. The trial is sponsored by Dana-Farber Cancer Institute and helps advance understanding of new options for these conditions.

Who may be eligible for this myeloid disease clinical trial?

Patients aged 12 years or older with relapsed or persistent AML, MDS, MPN, or JMML after stem cell transplant may be eligible. Both adults and pediatric patients can participate. Eligibility also depends on factors like disease status, organ function, and absence of active severe graft-versus-host disease. Please review eligibility criteria for more details.

Is there any cost to participate in this myeloid disease clinical trial?

Study-related care, including the investigational CIML NK cell infusion, chemotherapy, and all trial visits, is provided at no cost. Personal travel or other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional costs.

Actively Recruiting

Phase 1

Age: 12Years +

All Genders

ID04024761

Phase 1 Study of CIML NK Cell Infusion with IL-2 for Treating Relapsed Myeloid Diseases After Stem Cell Transplantation in Adults and Children 12 Years and Older

Led by Dana-Farber Cancer Institute · Updated on 2026-06-17

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating cytokine induced memory-like natural killer CIML NK cells combined with IL-2 in patients aged 12 years and older who have Acute Myeloid Leukemia AML, Myelodysplastic Syndromes MDS, Myeloproliferative Neoplasms MPN, or Juvenile Myelomonocytic Leukemia JMML that returned after stem cell transplantation. This Phase I clinical trial aims to test the safety and find the appropriate dose for this investigational treatment, which has not been approved by the FDA for relapsed disease. Participants receive intravenous infusions of CIML NK cells on day 0. Before this, patients are given chemotherapy drugs fludarabine daily for three doses starting on day -5 and cyclophosphamide on days -5 and -4 to prepare the body. The study includes both adult and pediatric patients who have relapsed after haploidentical or HLA-matched stem cell transplants. The treatment is followed for safety and response over several weeks. During the study, participants will be monitored closely for safety for six weeks and assessed for treatment response after 28 days. Further follow-ups include checking for leukemia-free survival and overall survival at 100 days and one year, as well as monitoring for acute and chronic graft-versus-host disease over several months to one year. The trial involves regular evaluations including bone marrow tests, blood tests, and clinical assessments to track disease status and side effects throughout participation.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 12Years +

All Genders

Eligibility Criteria

You may qualify if you...

Relapse or persistence of AML, MDS (including JMML), or MPN after stem cell transplant confirmed by measurable disease.
Disease persistence within 4 weeks before planned NK cell infusion and at least 2 weeks after immune suppression taper, with timing rules related to transplant date.
Availability of original stem cell donor willing and eligible for collection.
Age 12 years or older.
ECOG performance status of 2 or less; pediatric patients require Lansky or Karnofsky score of 50 or higher.
At least 20% donor T cell chimerism within 4 weeks before infusion.
Bone marrow involvement less than 80% within 4 weeks before infusion.
No systemic corticosteroids for GVHD above 5mg prednisone or equivalent for at least 4 weeks before infusion; allowed GVHD prophylaxis medications must be stopped 4 weeks prior.
No other systemic GVHD treatments for at least 4 weeks before infusion.
Ability to understand and sign informed consent.
Adequate organ function within 2 weeks of infusion, including bilirubin, liver enzymes, creatinine, oxygen saturation, and heart function.
Negative pregnancy test for women of childbearing potential.
Agreement to use contraception during and after study participation for men and women of childbearing potential.

You will not qualify if you...

Relapse involving immuno-privileged extramedullary sites like CNS, testes, or eyes.
Use of investigational agents within 4 weeks prior (6 weeks for some drugs), recent immunotherapy, or unresolved adverse events from prior treatments.
Prior donor lymphocyte infusion within 8 weeks before CIML NK infusion.
History of severe acute GVHD or active GVHD requiring systemic treatment.
Solid organ transplant recipients.
Allergic reactions to IL-2 or similar agents.
Autoimmune diseases like inflammatory bowel disease, rheumatoid arthritis, lupus, or autoimmune neuropathies (except Hashimoto's thyroiditis).
Uncontrolled illnesses including infection, heart failure, unstable angina, arrhythmia, or psychiatric conditions limiting compliance.
Critical illness before NK cell infusion contraindicating chemotherapy.
Pregnancy or breastfeeding.
HIV positive status.
Active uncontrolled hepatitis B or C, HIV, or HTLV-1 infection.
History of other malignancies unless in remission for 2 years or specific low-risk cancers treated within 2 years.

Research Team

Roman M. Shapiro, MD

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Phase 1 Study of CIML NK Cell Infusion with IL-2 for Treating Relapsed Myeloid Diseases After Stem Cell Transplantation in Adults and Children 12 Years and Older

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria