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RecruitingPhase 1 / Phase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
2 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The primary study endpoint is the feasibility and safety of infusion of the cells."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether special donor immune cells, called CIML-NK cells, can be made and safely given to people with acute myeloid leukemia (AML), a blood cancer. It also checks how well the cells treat AML. The study is for people age 2 or older whose AML has come back or has not responded to treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 2 or older when joining the study.
  • Have AML diagnosed using the 2016 World Health Organization rules.
  • Have AML that has come back or has not responded to treatment in the bone marrow, the soft tissue inside bones.
  • If AML has not responded: have at least 5% blasts (young cancer cells) in the bone marrow after 2 rounds of strong treatment to clear the cancer.
  • If AML has come back: have at least 5% blasts in the bone marrow, or blasts back in the blood, within 6 months of the first complete remission (when signs of cancer went away).
  • Have a related donor who is a half-match. Blood testing will check for antibodies that could react against the donor's cells before or when you join.
  • Have a daily activity score of at least 50% on the Karnofsky scale if older than 16, or the Lansky scale if age 16 or younger.

Who can't join

  • Have leukemia only in the brain or spinal cord, or only outside the bone marrow; or have acute promyelocytic leukemia (APML), a type of AML. Cancer outside the bone marrow is allowed if it is also in the bone marrow.
  • Have an active infection that is not controlled.
  • Have a heart pumping measurement below 45% on a heart ultrasound, or a blood oxygen level below 92% while breathing room air.
  • Have liver blood tests showing total bilirubin above 2 mg/dL and AST and ALT above 3 times the highest normal level.
  • Take a daily steroid dose above the lower of these two limits: the equivalent of 10 mg of prednisone, or 0.5 mg of prednisone per kilogram of body weight.
  • Receive another experimental treatment, or have a known allergy or sensitivity to IL-2 injections.
  • Be pregnant or breastfeeding. Female patients must have a pregnancy test.
  • Be able to have children but not agree to use effective birth control during treatment and for 6 months afterward. Options include birth control pills, patches, shots, an IUD, having tubes tied, a partner's vasectomy, or not having sex.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 * 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 sites (1)

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