Immune cell booster for leukemia patients pulled before start
NCT ID NCT07123662
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aimed to see if giving special immune cells (γδ T cells) after a stem cell transplant could help prevent leukemia from coming back in high-risk patients. It was planned for adults aged 18-65 with acute myeloid leukemia. However, the study was withdrawn before any participants were enrolled.
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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.
- Expected to start
-
Sep 2025
An estimate. Start dates often move.
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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 65 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. Patients voluntarily sign informed consent and are expected to complete the follow-up examination and treatment of the study procedures; 2. Age 18-65 years old (including cut-off value), gender is not limited; 3. AML patients have one of the high-risk factors for recurrence after allogeneic hematopoietic stem cell transplantation; 4. AML patients need to meet 30±5 days after the end of allogeneic transplant therapy; 5. The patient has recovered from the toxicity of the prior treatment, i.e., CTCAE toxicity grade \< 2 (unless the abnormality is related to the tumor or is stable as judged by the investigator and has little impact on safety or efficacy); 6. ECOG performance status score of 0-3 points and expected survival greater than 3 months ; 7. Have appropriate organ function: 1. Alanine aminotransferase (ALT) ≤3 times the upper limit of normal (ULN); 2. Aspartate aminotransferase (AST) ≤ 3 times ULN; 3. Total bilirubin ≤1.5 times ULN; 4. Serum creatinine ≤1.5 times ULN or creatinine clearance ≥ 60 mL/min; 5. Hemoglobin ≥ 50g/L (must not have received transfusion support within 7 days prior to laboratory tests); 6. Room oxygen saturation ≥92%; 7. Left ventricular ejection fraction (LVEF) ≥ 45%, echocardiography confirmed no pericardial effusion, no clinically significant ECG findings; 8. Without clinically significant pleural effusion; Exclusion Criteria: 1. Other malignant tumors within 3 years prior to screening, except for adequately treated carcinoma in situ of the cervix, papillary carcinoma of the thyroid, basal cell or squamous epithelial cell skin cancer, localized prostate cancer after radical resection, and ductal carcinoma in situ after radical resection; 2. Patients have a severe allergic history; 3. The patient has severe heart disease; 4. The patient has severe respiratory system disease; 5. Those with grade III\~IV acute GVHD or extensive chronic GVHD; 6. Patients who are using (or willing to use) other maintenance therapy drugs after hematopoietic stem cell transplantation and have proven that this maintenance therapy drug is not conducive to the persistence of γδ T cells in vivo; 7. Active neurological autoimmune or inflammatory diseases, amyotrophic lateral sclerosis (ALS), and clinically significant active cerebrovascular disease; 8. Patients with severe mental illness; 9. Alcoholics or those with a history of drug abuse; 10. Clinically significant active cerebrovascular disease; 11. Those who have participated in other clinical studies within 1 month before screening and have not interfered with the safety and efficacy of this study drug as assessed by the investigator are allowed to be included in the study, such as non-interventional observational studies; 12. Pregnant or lactating women, and female subjects who plan to become pregnant within 1 year after cell reinfusion or male subjects whose partners plan to become pregnant within 1 year after their cell reinfusion; 13. Any unsuitable to participate in this trial judged by the investigator.
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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.
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Other studies related to the condition(s) this trial covers.
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