Can supercharged immune cells stop leukemia from returning?
NCT ID NCT07237230
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether infusing special immune cells called γδ T cells can prevent relapse in people with high-risk acute myeloid leukemia (AML) who have had a stem cell transplant. The trial will enroll 40 adults aged 18 to 65. The main goal is to see if the treatment improves relapse-free survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- γδ T cells (a type of immune cell)
- What this could lead to
- If it works, this could offer a new way to prevent leukemia from coming back after a stem cell transplant, potentially improving long-term survival.
- What could go wrong
- This is an early, small trial with only 40 participants. The treatment may not prevent relapse and could cause side effects like graft-versus-host disease or infections.
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
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jul 2028
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 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. Voluntarily signs the informed consent form and is expected to be able to complete the follow-up examinations and treatments required by the study procedures. 2. Age 18 to 65 years (inclusive), regardless of gender. 3. Patients have one of the high-risk factors for relapse before allogeneic hematopoietic stem cell transplantation:①Meets the diagnostic criteria for relapsed or refractory disease as defined by the Chinese Guidelines for Diagnosis and Management of Relapsed/Refractory Acute Myeloid Leukemia (2017 Edition);②Hyperleukocytosis (≥100×10⁹/L) with concomitant central nervous system leukemia (CNSL); ③Positive minimal residual disease (MRD) before transplantation; ④Populations defined as having poor prognosis;⑤Myelodysplastic syndromes transformed to or secondary acute myeloid leukemia. 4. Confirmed diagnosis of Acute Myeloid Leukemia(AML) and within 30±5 days after allogeneic transplantation. 5. The subject has recovered from toxicities of previous therapies, defined as CTCAE grade \<2 (unless the abnormality is tumor-related or judged by the investigator to be stable with minimal impact on safety or efficacy). 6. Eastern Cooperative Oncology Group(ECOG) performance status score of 0-3 and an estimated life expectancy greater than 3 months. 7. Adequate organ function is defined as: 1. Alanine aminotransferase (ALT) ≤3 × upper limit of normal (ULN); 2. Aspartate aminotransferase (AST) ≤3 × ULN; 3. Total bilirubin ≤1.5 × ULN; 4. Serum creatinine ≤1.5 × ULN, or creatinine clearance ≥60 mL/min; 5. Hemoglobin ≥50g/L (must not have received transfusion support within 7 days prior to laboratory testing); 6. Room air oxygen saturation ≥92%; 7. Left ventricular ejection fraction (LVEF) ≥45%, confirmed by echocardiography without pericardial effusion and no clinically significant ECG findings; 8. No clinically significant pleural effusion. Exclusion Criteria: 1. Diagnosis of another malignancy within 3 years prior to screening, except for adequately treated carcinoma in situ of the cervix, papillary thyroid carcinoma, basal cell or squamous cell skin cancer, localized prostate cancer after radical surgery, or ductal carcinoma in situ after radical surgery; 2. History of severe allergy (defined as a grade 2 or higher allergic reaction manifested by any of the following: airway obstruction \[rhinorrhea, cough, wheezing, dyspnea\], tachycardia, hypotension, arrhythmia, gastrointestinal symptoms \[nausea, vomiting\], incontinence, laryngeal edema, bronchospasm, cyanosis, shock, respiratory or cardiac arrest) or known allergy to any active ingredient, excipient, murine-derived products, or xenogeneic proteins contained in the investigational product; 3. Severe cardiac disease, including but not limited to severe arrhythmia, unstable angina, large-area myocardial infarction, New York Heart Association Class III or IV cardiac dysfunction, or refractory hypertension (defined as failure to achieve blood pressure control after \>1 month of treatment with ≥3 tolerable antihypertensive drugs at optimal doses, including diuretics, or requiring ≥4 antihypertensive drugs for effective control); 4. Severe respiratory disease (including history of or concurrent severe interstitial lung disease, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, or symptomatic bronchospasm); 5. Presence of grade III-IV acute GVHD(Graft-Versus-Host Disease) or extensive chronic GVHD; 6. Current use (or intention to use) other maintenance therapies post-hematopoietic stem cell transplantation that have been demonstrated to adversely affect the persistence of γδ T cells in vivo; 7. Active neurological autoimmune or inflammatory diseases (e.g., Guillain-Barré syndrome \[GBS\], amyotrophic lateral sclerosis \[ALS\]) or clinically significant active cerebrovascular disease (e.g., cerebral edema, posterior reversible encephalopathy syndrome \[PRES\]); 8. Presence of severe psychiatric disorders; 9. History of alcohol abuse or drug abuse; 10. Clinically significant active cerebrovascular disease (e.g., cerebral edema, posterior reversible encephalopathy syndrome \[PRES\]); 11. Participation in another clinical study within 1 month prior to screening, unless deemed by the investigator as non-interfering with the safety and efficacy evaluation of the investigational product (e.g., non-interventional observational studies); 12. Women who are pregnant or breastfeeding, female subjects planning pregnancy within 1 year after cell infusion, or male subjects with partners planning pregnancy within 1 year after cell infusion; 13. Patients with contraindications to any study procedure or other medical conditions that may pose unacceptable risks, as determined by the investigator's judgment and/or clinical standards.
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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 places running it
1 site. The list below names each one and where it is.
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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
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
Locations
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Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
RECRUITINGWuhan, Hubei, 430000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New immune cell boost may shield kids from Post-Transplant infections
- New transplant recipe may tame Graft-Versus-Host disease in blood cancer patients
- Can a smartphone app improve quality of life for blood cancer patients?
- New drug combo aims to stop blood cancer relapse after transplant