Immune cells take on tough leukemia in early trial
NCT ID NCT05987696
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested a new treatment using lab-grown immune cells (iPSC NK cells) in 2 adults with hard-to-treat acute myeloid leukemia (AML) or signs of remaining disease after treatment. The main goal was to check safety and find the right dose. Researchers also looked for early signs that the cells were fighting the leukemia.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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2 people
The number who actually took part.
- Started
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Jul 2023
- Finished
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Jan 2025
- 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 years and older
- 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. Provision of signed and dated informed consent form (ICF). 2. ≥18 years old. 3. Eastern Cooperative Oncology Group (ECOG) performance status ≤1 and life expectancy greater than 12 weeks. 4. Diagnosis of r/r AML (Cohort 1 and 2) or AML MRD (Cohort 3). 5. Cohort 1: Both CLL1 and CD33 expression are positive in AML blasts; Cohort 2: The expression of CD33 in AML blast is positive. 6. Adequate organ and marrow function, as defined below: 1. Blood creatinine (Cr) ≤ 2 x ULN or calculated creatinine clearance (Cockcroft-Gault formula) ≥ 50 mL/min; 2. Total bilirubin (TBIL) ≤ 2 x the ULN; 3. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN; 4. International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN; 7. Females of childbearing potential must have a negative serum pregnancy test. 8. Donor specific antibody (DSA) is negative: MFI \<= 2000. Exclusion Criteria: 1. Allergic to drug used in this study. 2. Subjects received any antitumor therapy as follows, prior to first NK infusion: 1. Systemic steroid therapy within 3 days (except physiological replacement therapy); 2. Systemic antitumor therapy within 2 weeks or at least 5 half-lives, whichever is less; 3. Radiotherapy within 4 weeks; 4. Donor lymphocyte infusion within 6 weeks; 5. Intrathecal treatment within 1 week; 6. CAR-T therapy, CAR-NK therapy, or any other genetically modified cell therapy product within 6 months; 3. History of allogeneic stem cell transplantation. 4. Received the vaccine within 4 weeks prior to the first infusion and/or expected to require vaccination from the study period to 12 weeks after the last infusion. 5. Active central nervous system Leukemia. 6. Acute Promyelocytic Leukemia (APL). 7. History of other malignant tumors, except for those who have achieved complete remission more than 5 years after radical treatment without any signs of recurrence. 8. Active autoimmune diseases. 9. History of central nervous system disease or meningeal involvement such as epilepsy, paralysis, aphasia, stroke, etc. 10. Serious cardiovascular and cerebrovascular diseases: 1. Severe heart rhythm or conduction abnormalities, corrected QT interval (QTc)≥480 ms; 2. Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events within 6 months prior to first infusion; 3. New York Heart Association (NYHA) class II or above congestive heart failure or left ventricular ejection fraction (LVEF) \<50% in color Doppler echocardiography; 4. Hypertension that cannot be controlled by drug. 11. Active pulmonary infection; SpO2 ≤90%; Pulmonary embolism, chronic obstructive pulmonary disease, or interstitial lung disease. 12. Uncontrolled bacterial, fungal, or viral infection. Known HIV infection, active Hepatitis B (HBV) or Hepatitis C (HCV) infection. 13. History of substance abuse. 14. Toxicity induced by previous therapy not recovered to ≤ grade 2(NCI-CTCAE v5.0). 15. Large surgical treatment within 4 weeks prior to first infusion, not including diagnostic biopsy. 16. Pregnant/breastfeeding women. 17. Investigator-assessed presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to subject.
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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.
Contacts and locations
Locations
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Institute of Hematology & Blood Diseases Hospital
Tianjin, China
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