- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05580601
Cytokine-Induced Memory-Like Natural Killer Cells (CIML-NK) for Relapsed & Refractory Acute Myeloid Leukemia (AML)
March 29, 2024 updated by: Children's Hospital Medical Center, Cincinnati
Haploidentical Donor Cytokine-Induced Memory-Like Natural Killer Cells (CIML-NK) for Relapsed & Refractory Acute Myeloid Leukemia (AML)
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.
Study Overview
Detailed Description
The goal of treatment of relapsed or refractory acute myeloid leukemia (AML) is to achieve remission and proceed to hematopoietic stem cell transplant (HSCT).
Unfortunately, standard protocols have limited success.
In this study the investigators will identify patients with relapsed or refractory AML who are unlikely to benefit from standard chemotherapy protocols and do not qualify for, or do not wish to participate in, institutional chemotherapy trials.
Peripheral blood from a related haploidentical donor will be collected for the isolation of natural killer (NK) cells.
NK cells will be induced into a memory-like state using cytokine supplementation only.
In this Phase I/II study, Patients will receive a lymphodepleting chemotherapy regimen, after which the cytokine-induced memory-like NK cells (CIML-NKs) will be infused.
The primary study endpoint is the feasibility and safety of infusion of the cells.
The secondary endpoints are efficacy, as measured by clinical response per standard CR/CRi criteria and ability to subsequently undergo allogeneic HSCT, and the persistence of memory-like NK cells in the blood as measured by flow cytometry.
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Evelyn Nguyen
- Phone Number: 513-636-4379
- Email: Evelyn.Nguyen@cchmc.org
Study Contact Backup
- Name: Michele Wang
- Phone Number: 513-517-7219
- Email: YunZu.Wang@cchmc.org
Study Locations
-
-
Ohio
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Cincinnati, Ohio, United States, 45229
- Recruiting
- Cincinnati Children's Hospital Medical Center
-
Contact:
- Evelyn Nguyen
- Email: Evelyn.Nguyen@cchmc.org
-
Contact:
- Richard Cooper
- Email: richard.cooper@cchmc.org
-
Principal Investigator:
- Michele Wang, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Disease: isolated central nervous system (CNS) disease, or isolated extramedullary disease, or diagnosis of acute promyelocytic leukemia (APML). Patients with extramedullary disease in combination with bone marrow disease are eligible for enrollment.
- Infectious Disease: Active uncontrolled infection
- Renal function: radioisotope determined Glomerular Function Rate <50 mL/min/1.73m2
- Cardiac function: Systolic ejection fraction <45% by echocardiogram
- Pulmonary Function: Oxygen saturation <92% on room air
- Hepatic function: Total bilirubin > 2mg/dL, AST and ALT more than three times the upper limit of normal
- Concomitant medications: receiving either >10mg prednisone equivalent daily, or >0.5mg/kg prednisone equivalent daily, whichever is less
- Concomitant investigational treatments: receiving other investigational therapies
- Known allergy or hypersensitivity reaction to IL-2 injections
- Pregnant or breastfeeding women will not be entered on this study due to risks of fetal and teratogenic adverse events with lymphodepleting chemotherapy. Pregnancy tests must be obtained for female patients. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on study treatment and for six months following completion. Effective contraceptive methods include oral contraceptive pills, patches, or injections, intrauterine devices, having a tubal ligation, having a partner who has had a vasectomy, or not having sex.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
The 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:
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of infusion
Time Frame: 30 days
|
Number of patients who receive CIML-NK infusion without grade 3-4 infusional toxicity events as assessed by CTCAE v5.0 divided by the number of patients enrolled.
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Response to CIML-NK Infusion
Time Frame: 30 days
|
Clinical response to CIML-NK infusion assessed by bone marrow morphology per standard International Working Group CR/CRi criteria (Complete Remission (CR)
|
30 days
|
Persistence of CIML-NK cells in the recipients' peripheral blood
Time Frame: Assessed at day 7, 14, 21, 28
|
Persistence of CIML-NK cells in the recipients' peripheral blood, assessed by flow cytometry
|
Assessed at day 7, 14, 21, 28
|
Proceed to Hematopoietic Stem Cell Transplant (HSCT)
Time Frame: 6 months
|
Proportion of patients who are able to proceed to hematopoietic stem cell transplant
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Michele Wang, Children's Hospital Medical Center, Cincinnati
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 5, 2023
Primary Completion (Estimated)
February 1, 2025
Study Completion (Estimated)
July 1, 2026
Study Registration Dates
First Submitted
October 7, 2022
First Submitted That Met QC Criteria
October 12, 2022
First Posted (Actual)
October 14, 2022
Study Record Updates
Last Update Posted (Actual)
April 1, 2024
Last Update Submitted That Met QC Criteria
March 29, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-0853
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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