Haploidentical Donor Cytokine-Induced Memory-Like Natural Killer Cells (CIML-NK) for Relapsed & Refractory Acute Myeloid Leukemia (AML)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Healthy Volunteers: f
View:

• Of age ≥ 2 years of age at the time of study enrollment

• With AML diagnosed per 2016 WHO criteria (11)

• With relapsed or refractory AML in their bone marrow

• Refractory disease: Patients must have ≥ 5% blasts in the bone marrow after 2 courses of intensive induction treatment

• Relapsed disease: Patients must have ≥ 5% blasts in the bone marrow, or reappearance of blasts in the blood, within 6 months of initial CR

• With available haploidentical related donors. Donor specific antibody (DSA) testing will be done on the recipient prior to or upon enrollment.

• With performance level of ≥ 50% on Karnofsky scale for patients \> 16 years of age and ≥ 50% on Lansky scale for patients ≤ 16 years of age

Locations
United States
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Contact Information
Primary
Zahra Hudda
Zahra.Hudda@cchmc.org
917-754-7118
Backup
Caitlin Cottrell
Caitlin.cottrell@cchmc.org
513-803-7039
Time Frame
Start Date: 2023-05-05
Estimated Completion Date: 2027-07
Participants
Target number of participants: 20
Treatments
Experimental: Cytokine-Induced Memory-Like Natural Killer (CIML-NK) Cells
The investigational cell product is a cytokine-induced memory-like natural killer cell preparation, derived from the recipient's haploidentical donor's apheresis product.
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital Medical Center, Cincinnati

This content was sourced from clinicaltrials.gov