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New treatment option for Acute Myeloid Leukemia Refractory
Official title A Study of Natural Killer Cells in Combination With Atezolizumab in People With Acute Myelogenous Leukemia
ClinicalTrials.gov ID: NCT07011004
What this study is testing
What is Cytokine Induced Memory-Like Natural Killer Cells?
Cytokine Induced Memory-Like Natural Killer Cells is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for acute myeloid leukemia refractory.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The researchers are doing this study is to find the highest dose of cytokine-induced memory-like (CIML) natural killer (NK) cells in combination with the drug atezolizumab that causes few or mild side effects in people with relapsed/refractory acute myelogenous leukemia (AML). The researchers will also look at whether the treatment combination works against participants' cancer.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Disease specific
- people must have histologically confirmed acute myeloid leukemia that meets any of the following criteria:
- Refractory to at least two attempts at prior induction therapy. An attempt is defined as either a single cycle of combination chemotherapy such as...
- Patients with FLT3-ITD or -TKD mutations must have received at least one commercially available inhibitor of FLT3.
- Patients with NPM1 mutation or rearrangements of MLL must be refractory to revumenib.
You likely can't join if
- Prior allogeneic hematopoietic cell transplantation.
- people with active/uncontrolled CNS leukemia. people with prior CNS disease must have no detectable evidence of CSF disease for at least 4 weeks...
- people requiring systemic immunosuppression for any indication are excluded.
- Significant cardiovascular disease, as defined by:
- New York Heart Association Class II or greater congestive heart failure.
- Myocardial infarction, cerebrovascular accident, or other arterial vascular disease within 6 months prior to initiation of study treatment
See the full eligibility criteria
Who can join
- Disease specific
- people must have histologically confirmed acute myeloid leukemia that meets any of the following criteria:
- Refractory to at least two attempts at prior induction therapy. An attempt is defined as either a single cycle of combination chemotherapy such as daunorubicin/anthracycline OR a single monthly cycle of a...
- Patients with FLT3-ITD or -TKD mutations must have received at least one commercially available inhibitor of FLT3.
- Patients with NPM1 mutation or rearrangements of MLL must be refractory to revumenib.
- Patients with mutations in IDH1 or IDH2 must be refractory to at least one commercially available inhibitor of IDH1 or IDH2, respectively.
- Relapsed AML when relapse occurred within 6 months of achieving an initial complete remission.
- Patients must have either failed prior FDA approved agents or, in the opinion of the treating physician, have a sufficiently low probability of response to existing FDA approved agents to warrant treatment on an...
- Patients aged 18 through 70 years old are eligible.
- Must have an available, haplotype mismatched related individual that meets criteria for cell donation according to the FACT guidelines.
- Patients must have Karnofsky performance status ≥70%.
- Adequate cardiac function as defined as a systolic LV ejection fraction ≥50% at rest and absence of New York Heart Association stage III or IV congestive heart failure.
- Adequate pulmonary function as defined as a resting SpO2 ≥ 92% on room air at rest.
- Serum bilirubin ≤ 5 mg/dL.
- AST and ALT ≤ 2.5x ULN unless thought to be disease related.
- Estimated or measured creatinine clearance \> 50 mL/min.
- people must be free from all systemic immune suppression for at least 4 weeks prior to the start of intended therapy.
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs, as defined below: Women must remain abstinent...
- Negative HIV test at screening.
- Negative hepatitis B surface antigen (HBsAg) test at screening OR positive HBsAg is allowed if a negative HBcAb or a negative quantitative hepatitis B virus (HBV) (DNA \< 500 IU/mL) assay are documented.
- Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening The HCV RNA test must be performed for patients who have a positive HCV...
- For patients receiving therapeutic anticoagulation: Stable anticoagulant regimen for 2 weeks prior to enrollment.
- Timing of treatment relative to prior therapies:
- Bridging therapy with hydrea is allowed but is required to be tapered off prior to NK infusion.
- Any experimental biological treatments must be discontinued for at least 5 half-lives prior to initiation of study therapy.
- Patients must be \>5 half-lives from receipt of other cytotoxic or targeted therapy.
What rules you out
- Prior allogeneic hematopoietic cell transplantation.
- people with active/uncontrolled CNS leukemia. people with prior CNS disease must have no detectable evidence of CSF disease for at least 4 weeks prior to enrollment.
- people requiring systemic immunosuppression for any indication are excluded.
- Significant cardiovascular disease, as defined by:
- New York Heart Association Class II or greater congestive heart failure.
- Myocardial infarction, cerebrovascular accident, or other arterial vascular disease within 6 months prior to initiation of study treatment
- Unstable arrhythmia
- Unstable angina
- people with isolated extramedullary disease without evidence of bone marrow involvement by immunohistochemistry.
- Female patients who are pregnant or breast-feeding or intend to become pregnant during study treatment or within 5 months after the final dose of atezolizumab. Women of childbearing potential must have a negative serum...
- Severe or uncontrolled infection prior to initiation of study treatment.
- Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment, excluding prophylactic antimicrobial agents.
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed...
- Uncontrolled or symptomatic hypercalcemia (ionized calcium \> 1.5 mmol/L, calcium \>12 mg/dL, or corrected calcium greater than ULN)
- Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel...
- Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.
- Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
- Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all following...
- Rash must cover \< 10% of body surface area.
- Disease is well controlled at baseline and requires only low-potency topical corticosteroids.
- There has been no occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or...
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
- Persons who do not meet the age and organ function criteria specified above.
- History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
- Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation. Donor Inclusion Criteria:
- Donors must be eligible for apheresis according to standard FACT guidelines.
- Donors must not have an HLA genotype reactive against anti-HLA antibodies in the recipient.
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Rockville Centre, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.