Preemptive CIML NK Cell Therapy After Hematopoietic Stem Cell Transplantation
NCT06138587 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2026-01-02
Summary
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
- Acute Myeloid Leukemia
- Leukemia
- Leukemia, Myeloid
- Myelodysplastic Syndromes
- Myeloproliferative Neoplasm
- Myeloproliferative Disorders
Interventions
- BIOLOGICAL
-
Cytokine Induced Memory-like Natural Killer Cells
Allogeneic, cytokine induced memory-like natural killer cells, via intravenous infusion per protocol.
- BIOLOGICAL
-
Interleukin-2
Recombinant, human glycoprotein, single-use 22 MIU vials, via subcutaneous injection per protocol.
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Roman Shapiro, MD · Dana-Farber Cancer Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-24
- Primary Completion
- 2027-02-28
- Completion
- 2027-11-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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