Donor cells take on tough leukemia in early trial
NCT ID NCT04220684
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tested the safety of giving donor natural killer (NK) cells to 19 patients with acute myeloid leukemia that had returned or not responded to treatment. Patients first received chemotherapy, then up to six infusions of specially grown NK cells from a donor. The main goal was to find a safe dose and watch for side effects, especially graft-versus-host disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- donor natural killer cells (KDS-1001) plus chemotherapy (cytarabine and fludarabine)
- What this could lead to
- If it works, this could point toward a new treatment option for patients with hard-to-treat acute myeloid leukemia.
- What could go wrong
- This is a very early (phase 1) safety trial with only 19 people, so it is not yet known if the treatment works. There are risks of serious side effects like graft-versus-host disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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19 people
The number who actually took part.
- Started
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Jun 2020
- Finished
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Oct 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Patient Inclusion Criteria for Induction Phase * Primary Relapsed AML including * Relapsed AML after allogeneic stem cells * Isolated CNS or extramedullary disease (Note: a response monitoring plan must be developed a priori for subjects with extramedullary disease) * 1-3 prior lines of therapy which includes chemotherapy, hypomethylating agents, venetoclax or targeted therapy. * Patient weight ≥ 42 kg * Performance status: Karnofsky or Lansky Performance Scale (PS) greater or equal to 70, or, ECOG score 0-2. * Renal function: Serum creatinine ≤ 2 mg/dl and/or creatinine clearance greater or equal than 40 cc/min. * Pulmonary function: FEV1, FVC and DLCO ≥ 50% of expected, corrected for hemoglobin. * Liver function: Total bilirubin ≤ 2 mg/dl or ≤ 2.5 x ULN for age (unless Gilbert's syndrome) and SGPT (ALT) ≤ 2.5 x ULN for age. * Cardiac function: left ventricular ejection fraction ≥ 40%. * CNS: Patients with seizure disorder are eligible if seizures well controlled. * Negative serum test to rule out pregnancy within 2 weeks prior to enrollment in females of childbearing potential (non-childbearing potential defined as premenarchal, greater than one year post-menopausal, or surgically sterilized). * Sexually active males and females of childbearing potential must agree to use a form of contraception considered effective and medically acceptable by the Investigator. * Ability to understand and willingness to sign the written informed consent document. * Negative serology for human immunodeficiency virus (HIV). * Patients on hydrocortisone for adrenal insufficiency or on inhaled or topical steroids are eligible. Maintenance Phase: Patients that complete induction therapy and who achieve a CR/CRi/PR within the designated follow-up period and who are ineligible, unable or unwilling to undergo HSCT; these patients will not receive fludarabine or cytarabine. Exclusion Criteria for Induction Phase: * Investigational therapies in the 3 weeks prior to beginning treatment on this protocol. * Patients receiving any concurrent therapy including but not limited to chemotherapy, targeted therapy, radiation therapy, or immunotherapy for R/R AML. * Any comorbidities that in the opinion of the investigator will preclude receiving fludarabine or cytarabine. * Uncontrolled infection, defined as an infection which has not resolved spontaneously or does not show evidence of significant resolution after initiating appropriate therapy. Asymptomatic viremia such as CMV, HPV, BK virus, HCV, HBV etc. is NOT considered as an exclusion criteria. * Uncontrolled arrhythmias or uncontrolled symptomatic cardiac disease. * Active GVHD * Prednisone dose is \> 20 mg/day or \>0.25mg/kg, whichever is higher will be excluded. * Patients with donor-specific antibodies with MFI \> 5000 will be ineligible * Maintenance Phase: Patients must continue to meet exclusion criteria as defined in Section 4.4.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
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Oregon Health & Science University
Portland, Oregon, 24344, United States
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