Cytokine-Induced Memory-Like Natural Killer Cells (CIML-NK) for Relapsed & Refractory Acute Myeloid Leukemia (AML)
Part of paid clinical trials in Cincinnati, Ohio.
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Study ID
- NCT05580601
- Phase
- PHASE1/PHASE2
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 2 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- CIML-NK Cells — DRUGThe investigational cell product is a cytokine-induced memory-like natural killer cell preparation, derived from the recipient's haploidentical donor's apheresis product. At the time of infusion, the product is comprised of: * Cytokine-Induced Memory-Like NK cells (CIML-NK cells) * Human Serum Albumin * Plasmalyte The concentration and total cell number of CIML-NK cells in the product will vary based on the recipient body weight and the dose requested.
Study Details
The objective of this study is to demonstrate that cytokine-induced memory-like natural killer cells can be generated from donor cells and infused safely into patients with relapsed or refractory acute myeloid leukemia (AML). A secondary objective is to assess efficacy of the CIML-NK cells in treating AML.
Key Dates
- Start date
- May 5, 2023
- Status verified
- Feb 2026
- Primary completion
- Jan 31, 2027
- Completion
- Jul 31, 2027
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Cytokine-Induced Memory-Like Natural Killer (CIML-NK) CellsThe investigational cell product is a cytokine-induced memory-like natural killer cell preparation, derived from the recipient's haploidentical donor's apheresis product.
Primary Outcome Measure
Feasibility of infusion [ Time Frame: 30 days ]
Central Contacts
- Zahra Hudda917-754-7118
- Caitlin Cottrell513-803-7039
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | Caitlin Cottrell Richard Cooper Michele Wang, MD (PRINCIPAL_INVESTIGATOR) |
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