Actively Recruiting
Preemptive CIML NK Cell Therapy After Hematopoietic Stem Cell Transplantation
Led by Dana-Farber Cancer Institute · Updated on 2026-01-02
15
Participants Needed
2
Research Sites
200 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this research study is to test the safety and efficacy of cytokine induced memory-like (CIML) natural killer (NK) cells expanded with Interleukin-2 (IL-2) at preventing relapse in acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or MDS and myeloproliferative neoplasm (MPN) overlap syndrome after a standard-of-care stem cell transplant. Names of the study therapies involved in this study are: * CIML NK cells intravenous infusion (cellular therapy) * Subcutaneous Interleukin-2 (recombinant, human glycoprotein)
CONDITIONS
Official Title
Preemptive CIML NK Cell Therapy After Hematopoietic Stem Cell Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of AML, MDS, or MDS/MPN at high risk for relapse after transplant, with measurable disease before transplant or TP53 mutation
- Adequate organ function within 2 weeks before NK cell infusion (bilirubin, liver enzymes, creatinine, oxygen saturation, heart function)
- Age 18 or older and planned for reduced intensity conditioning allogeneic stem cell transplant with related donor
- AML in complete remission according to 2017 ELN guidelines; MDS/MDS/MPN with less than 10% bone marrow blasts
- Related donor available to provide apheresis product after stem cell donation
- ECOG performance status of 2 or less (Karnofsky 60% or higher)
- Negative pregnancy test for women of childbearing age
- Agreement to use contraception during and after study participation
- No laboratory evidence of ongoing hemolysis
You will not qualify if you...
- Expected to benefit more from myeloablative conditioning than reduced intensity conditioning
- Planned use of targeted maintenance therapy (e.g., FLT3-ITD, IDH, BCR-ABL mutations)
- Leukemia in sanctuary sites inaccessible to immune surveillance like CNS or testis
- Planned use of sirolimus for graft-versus-host disease prophylaxis
- Prior non-standard allogeneic stem cell transplant or solid organ transplant
- Allergic reactions to cellular products
- Uncontrolled infections, symptomatic heart failure, unstable angina, arrhythmias, or psychiatric/social issues limiting compliance
- Pregnancy or breastfeeding
- HIV positive
- Active uncontrolled Hepatitis B or C
- History of other malignancies not in remission or treated under specified conditions
- Allergic reactions to IL-2 or similar agents
- Prior grade 2 or higher hemolytic anemia
- Use of systemic steroids on day of NK cell infusion or high dose steroids within 4 weeks prior
- Recent investigational or immunotherapy agents within specified washout periods
- Presence of donor-specific antibodies without proper management
- Significant clinical changes increasing risk at time of NK cell infusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
Research Team
R
Roman 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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