Actively Recruiting
A Phase 1 Trial of CIML NK Cell Infusion for Myeloid Disease Relapse After Hematopoietic Cell Transplantation
Led by Dana-Farber Cancer Institute · Updated on 2026-04-03
50
Participants Needed
2
Research Sites
378 weeks
Total Duration
On this page
Sponsors
D
Dana-Farber Cancer Institute
Lead Sponsor
T
The Leukemia and Lymphoma Society
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research study is studying cytokine induced memory-like natural killer (CIML NK) cells combined with IL-2 in adult patients (18 years of age or older) with Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS) and Myeloproliferative Neoplasms (MPN) who relapse after haploidentical hematopoietic cell transplantation (haplo-HCT) or HLA matched stem cells. This study will also study CIML NK cell infusion combined with IL-2 in pediatric patients (12 years of age or older) with AML, MDS, JMML who relapse after stem cell transplantation using HLA-matched related donor or related donor haploidentical stem cells.
CONDITIONS
Official Title
A Phase 1 Trial of CIML NK Cell Infusion for Myeloid Disease Relapse After Hematopoietic Cell Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Relapse or persistent AML, MDS (including JMML), or MPN after stem cell transplantation
- Disease persistence within 4 weeks before planned NK cell infusion and at least 2 weeks after immune suppression taper
- Original donor available and eligible for non-mobilized collection
- Age 12 years or older
- ECOG performance status 2 or less (Lansky/Karnofsky 50 or more for pediatric patients)
- T cell chimerism 20% or more donor-derived within 4 weeks before infusion
- Bone marrow involvement 80% or less within 4 weeks before infusion
- No systemic corticosteroids for GVHD for at least 4 weeks before infusion
- 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 before infusion
- Negative pregnancy test for women of childbearing potential
- Agreement to use contraception during study participation
You will not qualify if you...
- Extramedullary relapse in immune-privileged sites (CNS, testes, eyes)
- Use of investigational agents or immunotherapy within specified recent timeframes
- Prior Donor Lymphocyte Infusion within 8 weeks before CIML NK infusion
- History of severe acute GVHD or ongoing active GVHD requiring treatment
- Solid organ transplant recipients
- Allergic reactions to IL-2 or study agents
- History of certain autoimmune diseases (except Hashimoto's thyroiditis)
- Uncontrolled illness including infection or heart conditions
- Critical illness preventing chemotherapy conditioning before infusion
- Pregnant or breastfeeding women
- HIV positive participants
- Active uncontrolled hepatitis B, C, HIV, or HTLV-1 infection
- History of other malignancies unless in remission or specific exceptions apply
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
R
Roman M. Shapiro, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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