Trial Testing Safety of IL-21 NK Cells for Induction of R/R AML (NCT04220684) | Clinical Trial Compass
CompletedPhase 1
Trial Testing Safety of IL-21 NK Cells for Induction of R/R AML
United States19 participantsStarted 2020-06-11
Plain-language summary
This phase I trial studies the side effects of donor natural killer (NK) cell therapy in treating patients with acute myeloid leukemia that has come back (recurrent) or has not responded to treatment (refractory). Natural killer cells are a type of immune cell. Immunotherapy with genetically modified NK cells from donors may induce changes in the body's immune system and may interfere with the ability of cancer cells to grow and spread.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Neg…
What they're measuring
1
Maximum tolerated dose (MTD) of membrane-bound interleukin-21-expanded haploidentical natural killer (NK) cells