High-Risk Acute Myeloid LeukemiaNCT07237230
Clinical Study to Evaluate the Safety and Efficacy of γδ T Cells for the Prevention of Relapse After Allogeneic Transplantation in Patients With High-risk Acute Myeloid Leukemia
A study testing allogeneic γδ T cell infusion in people with High-Risk Acute Myeloid Leukemia, run by Donghua Zhang at 1 site in China.
Trial summary
This is an investigator-initiated clinical trial evaluating the safety and efficacy of allogeneic γδ T cell infusion for relapse prevention in high-risk acute myeloid leukemia patients after transplantation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- High-Risk Acute Myeloid Leukemia
- What is being tested?
- allogeneic γδ T cell infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Age 18 to 65 years (inclusive), regardless of gender.
- 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.
- Confirmed diagnosis of Acute Myeloid Leukemia(AML) and within 30±5 days after allogeneic transplantation.
- 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).
- Eastern Cooperative Oncology Group(ECOG) performance status score of 0-3 and an estimated life expectancy greater than 3 months.
Show all 15Show fewer
- Adequate organ function is defined as:
- Alanine aminotransferase (ALT) ≤3 × upper limit of normal (ULN);
- Aspartate aminotransferase (AST) ≤3 × ULN;
- Total bilirubin ≤1.5 × ULN;
- Serum creatinine ≤1.5 × ULN, or creatinine clearance ≥60 mL/min;
- Hemoglobin ≥50g/L (must not have received transfusion support within 7 days prior to laboratory testing);
- Room air oxygen saturation ≥92%;
- Left ventricular ejection fraction (LVEF) ≥45%, confirmed by echocardiography without pericardial effusion and no clinically significant ECG findings;
- No clinically significant pleural effusion.
Who cannot join
- 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;
- 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;
- 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);
- Severe respiratory disease (including history of or concurrent severe interstitial lung disease, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, or symptomatic bronchospasm);
- Presence of grade III-IV acute GVHD(Graft-Versus-Host Disease) or extensive chronic GVHD;
- 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;
Show all 13Show fewer
- 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]);
- Presence of severe psychiatric disorders;
- History of alcohol abuse or drug abuse;
- Clinically significant active cerebrovascular disease (e.g., cerebral edema, posterior reversible encephalopathy syndrome [PRES]);
- 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);
- 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;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Andie Fu, 15926614832, andie_fu@163.com
About this study
Official title: Clinical Study Protocol to Evaluate the Safety and Efficacy of γδ T Cells for the Prevention of Relapse After Allogeneic Transplantation in Patients With High-risk Acute Myeloid Leukemia
This is an investigator-initiated clinical trial evaluating the safety and efficacy of allogeneic γδ T cell infusion for relapse prevention in high-risk acute myeloid leukemia patients after transplantation.
- Conditions
- High-Risk Acute Myeloid Leukemia
- Being tested
- allogeneic γδ T cell infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allogeneic γδ T cell infusionBiological
allogeneic γδ T cell infusion
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Biological: allogeneic γδ T cell infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-Free Survival (RFS)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start1 Jul 2025
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-Risk Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Donghua Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Donghua Zhang, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237230
- Sponsor's protocol ID
- DHZ1962-C
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Protocol to Evaluate the Safety and Efficacy of γδ T Cells for the Prevention of Relapse After Allogeneic Transplantation in Patients With High-risk Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT07237230
- Acronym / sponsor ID
- DHZ1962-C
- Conditions
- High-Risk Acute Myeloid Leukemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Donghua ZhangUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an investigator-initiated clinical trial evaluating the safety and efficacy of allogeneic γδ T cell infusion for relapse prevention in high-risk acute myeloid leukemia patients after transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Biological: allogeneic γδ T cell infusion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
- Age 18 to 65 years (inclusive), regardless of gender.
- 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.
- Confirmed diagnosis of Acute Myeloid Leukemia(AML) and within 30±5 days after allogeneic transplantation.
- 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).
Key exclusion criteria (13 listed)
- 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;
- 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;
- 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);
- Severe respiratory disease (including history of or concurrent severe interstitial lung disease, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, or symptomatic bronchospasm);
- Presence of grade III-IV acute GVHD(Graft-Versus-Host Disease) or extensive chronic GVHD;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| allogeneic γδ T cell infusionallogeneic γδ T cell infusion | Biological | Experimental group |
Primary outcome
Relapse-Free Survival (RFS)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
Related trials for High-Risk Acute Myeloid Leukemia
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
RecruitingPhase 1
First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-risk Myelodysplastic Syndrome (HR-MDS)
R/R AML, R/R HR-MDS
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing allogeneic γδ T cell infusion in people with High-Risk Acute Myeloid Leukemia, run by Donghua Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andie Fu (15926614832, andie_fu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse-Free Survival (RFS) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.