Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Immune cell combo targets stubborn leukemia in early trial

NCT ID NCT07011004

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a new treatment for adults with acute myeloid leukemia (AML) that has come back or not responded to standard therapy. The treatment combines specially trained natural killer (NK) immune cells with a drug called atezolizumab. The main goal is to find a safe dose and see if the combination can shrink the cancer. About 18 participants will be enrolled.

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

About 18 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

May 2028

An estimate. End dates often move.

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 to 70 years

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: Disease specific inclusion criteria: * Subjects 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 hypomethylating agent with venetoclax. * 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 investigational protocol. Other inclusion criteria: * 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. * Subjects 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 or use contraceptive methods with a failure rate of \<1% per year during the treatment period and for 5 months after the final dose of atezolizumab. Women must refrain from donating eggs during this same period. * 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 antibody test. * 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. Exclusion Criteria: * Prior allogeneic hematopoietic cell transplantation. * Subjects with active/uncontrolled CNS leukemia. Subjects with prior CNS disease must have no detectable evidence of CSF disease for at least 4 weeks prior to enrollment. * Subjects 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 * Subjects 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 pregnancy test result within 14 days prior to initiation of study treatment with atezolizumab. * 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 tomography (CT) scan. * 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 disease, anti-phospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions: * 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 conditions are met: * 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 oral corticosteroids within the previous 12 months. * 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acute myeloid leukemia refractory are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    7 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    RECRUITING

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

    Contact Email: •••••@•••••

  • Memorial Sloan Kettering Monmouth (Limited protocol activities)

    RECRUITING

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau (Limited Protocol Activites)

    RECRUITING

    Rockville Centre, New York, 11553, United States

  • Memorial Sloan Kettering Suffolk - Commack (Limited protocol activities)

    RECRUITING

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering West Harrison (Limited Protocol Activities)

    RECRUITING

    Harrison, New York, 10604, United States

  • Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

    RECRUITING

    Basking Ridge, New Jersey, 07920, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.