Expansion, persistence, and efficacy of donor memory-like NK cells infused for posttransplant relapse.
Roman M Shapiro, Grace C Birch, Guangan Hu...
https://pubmed.ncbi.nlm.nih.gov/35349491Actively Recruiting
Phase 1
Age: 12Years +
All Genders
ID04024761
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
N/A
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
Researchers are evaluating cytokine induced memory-like natural killer (CIML NK) cells combined with IL-2 in adults aged 18 and older with Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), and Myeloproliferative Neoplasms (MPN) who have relapsed after haploidentical or HLA matched stem cell transplantation. The study also includes pediatric patients aged 12 and older with AML, MDS, and Juvenile Myelomonocytic Leukemia (JMML) who relapse after stem cell transplantation. This is a Phase I clinical trial focused on testing the safety and determining the appropriate dose of these investigational CIML NK cells, which have not yet been approved by the FDA for relapsed disease treatment. The treatment involves intravenous infusion of CIML NK cells on day 0. Prior to this, patients receive chemotherapy with fludarabine administered once daily for three doses starting on day -5, and cyclophosphamide given on days -5 and -4. This regimen is designed to prepare the body for CIML NK cell infusion. Both adult and pediatric patients undergo this treatment schedule. Participants will be closely monitored for safety over 6 weeks, with additional evaluations including objective response rate at 28 days, and assessments for leukemia-free survival and overall survival at 100 days and one year. Researchers will also track the incidence and severity of acute and chronic graft-versus-host disease over time. The study involves various tests such as bone marrow examinations, blood tests, and pregnancy tests when applicable. Participants must meet eligibility criteria and provide informed consent to join this study, which continues until the end date in December 2026.
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 persistent disease of AML, MDS (including JMML), or MPN after stem cell transplantation confirmed by tests
- Disease persistence within 4 weeks before planned NK cell infusion and at least 2 weeks after stopping immune suppression, with timing rules based on transplant date
- Original donor available and eligible for cell collection
- Age 12 years or older
- ECOG performance status 0 to 2, or equivalent Lansky/Karnofsky score in pediatric patients
- At least 20% donor-derived T cell chimerism within 4 weeks prior to infusion
- Bone marrow involvement less than 80% within 4 weeks prior to infusion
- No systemic corticosteroid treatment for graft-versus-host disease for at least 4 weeks before infusion
- No other systemic treatments for graft-versus-host disease for at least 4 weeks before infusion
- Ability to understand and sign informed consent
- Adequate organ function within 2 weeks before infusion (specific lab values and heart function)
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective contraception during and after the study period
You will not qualify if you...
- Relapse in immune-privileged sites like CNS, testes, or eyes
- Use of investigational agents or immunotherapy within specified time frames before infusion
- Recent donor lymphocyte infusion within 8 weeks before CIML NK infusion
- History of severe acute graft-versus-host disease or ongoing active GVHD needing systemic treatment
- Solid organ transplant recipients
- Allergic reactions to IL-2 or similar agents
- History of autoimmune diseases such as rheumatoid arthritis, lupus, or inflammatory bowel disease
- Uncontrolled infections, severe heart problems, or psychiatric/social conditions preventing study compliance
- Critical illness preventing chemotherapy or infusion within the planned schedule
- Pregnant or breastfeeding women
- HIV-positive status or active uncontrolled hepatitis B, C, or HTLV-1
- History of other malignancies unless in complete remission for at least 2 years or specific exceptions apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 2 weeks
Participants receive chemotherapy with Fludarabine and Cyclophosphamide before receiving an infusion of CIML NK cells.
1 baseline visit and daily visits for 5 days around infusion
Follow-up
Duration - Up to 6 weeks
Participants are monitored for safety and treatment response after CIML NK cell infusion.
Weekly visits for up to 6 weeks
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
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Research Team
R
Roman M. Shapiro, MD
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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