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Donor cells take on tough leukemia in early trial

NCT ID NCT04220684

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

19 people

The number who actually took part.

Started

Jun 2020

Finished

Oct 2024

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

acute myeloid leukemia Myelodysplastic Syndromes

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

  • Oregon Health & Science University

    Portland, Oregon, 24344, United States

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