Engineered immune cells take on tough leukemia in early trial
NCT ID NCT07336875
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests a new type of cell therapy called CAR-ITNK cells, designed to target two proteins (CD70 and CLL1) on leukemia cells. It will enroll 30 adults with relapsed or refractory acute myeloid leukemia (AML) who have not responded to standard treatments. Participants receive a single infusion of these engineered cells after chemotherapy to prepare the body, and are followed for three years to check safety and how well the leukemia responds.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CAR-ITNK cells targeting CD70 and CLL1
- What this could lead to
- If successful, this could offer a new treatment option for patients with hard-to-treat acute myeloid leukemia that has not responded to standard therapies.
- What could go wrong
- This is a very early, small trial (30 people) focused on safety, so it may not lead to an effective treatment. Cell therapies can cause severe side effects like cytokine release syndrome.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: 1\. The patient or their legal guardian voluntarily participates and has signed the informed consent form. 2\. Age between 18 and 75 years old (inclusive), with no gender restrictions. 3. Diagnosed as having refractory/relapsed acute myeloid leukemia, meeting one of the following criteria: 1. . Reappearance of leukemic cells in peripheral blood after achieving complete remission, or bone marrow blast count \> 5% (excluding other causes such as bone marrow reconstitution post-consolidation chemotherapy), or the presence of extramedullary leukemic cell infiltration. 2. . Ineligible for bone marrow transplantation, or have undergone bone marrow transplantation but failed to achieve long-term remission. 4\. Expression of both CLL-1 and CD70 targets is confirmed as positive by flow cytometry. 5\. Patients must have good major organ function: 1. . Liver function: ALT/AST \< 3 times the upper limit of normal (ULN) and total bilirubin ≤ 34.2 μmol/L. 2. . Kidney function: Creatinine clearance rate (Cockcroft-Gault method) ≥ 60 mL/min. 3. . Lung function: Oxygen saturation ≥ 95%, with no active pulmonary infection. 4. . Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%; no significant pericardial effusion, and no clinically significant ECG abnormalities. 6\. Women of childbearing age must have a negative urine/blood pregnancy test during screening and agree to use contraceptive measures for at least 1 year after infusion. Male subjects with reproductive capacity must agree to use effective barrier contraception for at least 1 year after infusion. 7\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3. 8. Expected life expectancy greater than 3 months. 9. The patient is willing to cooperate with the collection of peripheral blood mononuclear cells, medical examinations, and regular follow-up visits. Exclusion Criteria: The patient will be excluded if meeting any of the following criteria: 1. Women who are pregnant or breastfeeding. 2. Presence of uncontrolled fungal, bacterial, treponemal (e.g., syphilis), viral, or other infections. 3. Active hepatitis B (Hepatitis B virus DNA \> 500 IU/mL) or a positive Hepatitis C virus RNA (HCV-RNA) test. 4. Human Immunodeficiency Virus (HIV) infection, or syphilis infection. 5. Previously received any form of gene therapy. 6. The patient has an allergic constitution or is allergic to macromolecular biologics such as antibodies or cytokines. 7. History of clinically significant central nervous system diseases, such as: epilepsy, hemiparesis, aphasia, stroke, severe brain trauma, dementia, Parkinson's disease, cerebellar diseases, or organic brain syndromes. 8. Uncontrolled psychiatric illness. 9. A history of drug abuse/addiction. 10. Use of prohibited medications: (1). Hormones: Use of corticosteroids (prednisone ≥ 2 mg/kg or equivalent \> 20 mg/day) within 2 weeks prior to cell collection. Recent or ongoing use of inhaled, topical, or non-absorbable steroids is not an exclusion criterion. (2). Radiotherapy/Chemotherapy:Receipt of radiotherapy or salvage chemotherapy for the study disease within 3 weeks prior to cell collection. (3). Use of immunosuppressive agents within 4 weeks prior to cell collection. (4). Participation in another clinical trial or receipt of a major non-diagnostic surgical procedure within 4 weeks prior to cell collection. (5). Use of alemtuzumab within 6 months, or cladribine/clofarabine within 3 months, prior to cell collection.
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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.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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