Actively Recruiting
Safety and Efficacy of Expanded, Universal Donor Natural Killer Cells for Relapsed/Refractory AML
Led by Nationwide Children's Hospital · Updated on 2024-11-04
20
Participants Needed
1
Research Sites
259 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase I/II dose escalation study designed to determine the safety and estimate the efficacy of UD-NK cells combined with FLA chemotherapy in patients age 1-24.99 with relapsed or refractory acute myeloid leukemia. PRIMARY OBJECTIVE: I. To determine the safety and recommended phase II dose of adoptive NK cell therapy using UD-NK cells in pediatric and young adult patients with relapsed/refractory AML. SECONDARY OBJECTIVES: I. To estimate the efficacy of UD- NK cells with FLA chemotherapy in pediatric and young adult patients with relapsed/refractory AML. EXPLORATORY OBJECTIVES: I. To determine the immunophenotype and function of UD-NK cells II. To characterize in vivo expansion of UD-NK cells III. To determine the persistence of UD-NK cells Six doses of universal donor mbIL-21 expanded NK cells (UD-NK) given thrice weekly for two weeks. Days may vary and NK cells can be given from days 0 to 21. Patients may receive up to 2 cycles of fludarabine/cytarabine (FLA) + NK cells (up to 12 NK cell infusions) if they do not achieve CR after cycle 1 or if necessary to bridge to transplant.
CONDITIONS
Official Title
Safety and Efficacy of Expanded, Universal Donor Natural Killer Cells for Relapsed/Refractory AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with relapsed or primary refractory AML, including those in first or subsequent relapse or after stem cell transplant
- Patients with primary refractory AML after 2 cycles of induction chemotherapy, including persistent minimal residual disease
- Patients with isolated CNS or extramedullary AML disease
- Age between 1 and 24.99 years
- Negative pregnancy test within 2 weeks prior to enrollment for females of childbearing potential
- Agreement to use effective contraception for 6 months after last chemotherapy or NK cell infusion for sexually active males and females of childbearing potential
- Negative HIV serology
- Adequate organ function: creatinine 64 2 mg/dl or creatinine clearance > 60 ml/min/1.73m2; total bilirubin 64 2 mg/dl (unless Gilbert's syndrome); AST and ALT 64 5x upper limit normal unless due to leukemia; cardiac ejection fraction 50% or shortening fraction 520%, with cardiology clearance if needed
- Controlled seizure disorder if applicable
- Prior treatment-related non-hematologic toxicities resolved to grade 2 or less
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- Receipt of AML-directed therapies within 2 weeks before starting study treatment (except hydroxyurea)
- Current use of systemic immunosuppressive therapy within 2 weeks prior to enrollment
- History of donor lymphocyte infusion or cellular therapy within 30 days
- Allogeneic stem cell transplant less than 3 months before enrollment
- Comorbidities that would prevent safe study treatment per investigator
- Karnofsky or Lansky performance status less than 50
- Uncontrolled infection not improving with treatment
- Uncontrolled arrhythmias or symptomatic cardiac disease
- History of autoimmune disease
- Active graft-versus-host disease at enrollment
- History of adoptive cell therapy within 30 days without hematologic recovery (ANC < 500/bcL or platelets < 50,000/bcL)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
Research Team
M
Melinda C Triplet
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here