LeukemiaEarly Phase 1NCT07123662
γδ T Cell Therapy for Relapse Prevention in High-Risk AML Post-Transplant
A Early Phase 1 study testing Gamma-Delta T cell injection and Standard prophylactic treatment in people with Leukemia and Myeloid, run by Guangzhou Bio-gene Technology Co., Ltd.
Trial summary
This is a prospective, double-arm, single-center, randomized controlled single-blind clinical study Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- Gamma-Delta T cell injection and Standard prophylactic treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 30 May 2028
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- Patients voluntarily sign informed consent and are expected to complete the follow-up examination and treatment of the study procedures;
- Age 18-65 years old (including cut-off value), gender is not limited;
- AML patients have one of the high-risk factors for recurrence after allogeneic hematopoietic stem cell transplantation;
- AML patients need to meet 30±5 days after the end of allogeneic transplant therapy;
- 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);
- ECOG performance status score of 0-3 points and expected survival greater than 3 months ;
Show all 15Show fewer
- Have appropriate organ function:
- Alanine aminotransferase (ALT) ≤3 times the upper limit of normal (ULN);
- Aspartate aminotransferase (AST) ≤ 3 times ULN;
- Total bilirubin ≤1.5 times ULN;
- Serum creatinine ≤1.5 times ULN or creatinine clearance ≥ 60 mL/min;
- Hemoglobin ≥ 50g/L (must not have received transfusion support within 7 days prior to laboratory tests);
- Room oxygen saturation ≥92%;
- Left ventricular ejection fraction (LVEF) ≥ 45%, echocardiography confirmed no pericardial effusion, no clinically significant ECG findings;
- Without clinically significant pleural effusion;
Who cannot join
- 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;
- Patients have a severe allergic history;
- The patient has severe heart disease;
- The patient has severe respiratory system disease;
- Those with grade III~IV acute GVHD or extensive chronic GVHD;
- 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;
Show all 13Show fewer
- Active neurological autoimmune or inflammatory diseases, amyotrophic lateral sclerosis (ALS), and clinically significant active cerebrovascular disease;
- Patients with severe mental illness;
- Alcoholics or those with a history of drug abuse;
- Clinically significant active cerebrovascular disease;
- 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;
- 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;
- Any unsuitable to participate in this trial judged by the investigator.
About this study
Official title: A Clinical Study on the Safety and Efficacy of γδ T Cells in Preventing Relapse After Allogeneic Transplantation in High-risk Acute Myeloid Leukemia Patients
This is a prospective, double-arm, single-center, randomized controlled single-blind clinical study
Read the detailed description
This study is a prospective, single-center, two-arm, single-blind randomized controlled clinical trial to evaluate the safety and efficacy of γδ T cell infusion in preventing recurrence in patients with high-risk AML after allogeneic transplantation.
- Being tested
- Gamma-Delta T cell injection, Standard prophylactic treatment
- Keywords
- γδ T cells, AML, Prevent recurrence
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamma-Delta T cell injectionBiological
Experimental group: Peripheral intravenous infusion of γδ T cells
Standard prophylactic treatmentOther
Standard prophylactic treatment
| Study group | Role | What they receive |
|---|---|---|
| Gamma-Delta T cell injection | Experimental | Experimental group: Received γδT infusion after high-risk AML allogene transplantation standard prophylactic treatment. Receives: Biological: Gamma-Delta T cell injection |
| Standard prophylactic treatment | Other | Control group: High-risk AML received only standard prophylactic treatment after allogeneic transplantation Receives: Other: Standard prophylactic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Count the Incidence of adverse events.
Measured: Up to 12 months.
Secondary outcomes (2)
Levels of peripheral blood γδ T cells after infusion（PK）
γδ T cells in the peripheral blood after infusion
Measured: Up to 12 months.
Concentration of Cytokine after Infusion (PD)
Calculate the change in cytokine concentrations in peripheral blood after γδ T cell infusion.
Measured: Up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 May 2028 (estimated)
- Study completion30 May 2028 (estimated)
Why it stopped: Due to corporate strategic adjustment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Bio-gene Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Donghua Zhang, MD, Study director, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07123662
- Sponsor's protocol ID
- BG-CT-24-021
- Status last verified
- May 2026
- First submitted
- 8 Aug 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Safety and Efficacy of γδ T Cells in Preventing Relapse After Allogeneic Transplantation in High-risk Acute Myeloid Leukemia Patients
- ClinicalTrials.gov ID
- NCT07123662
- Acronym / sponsor ID
- BG-CT-24-021
- Keywords
- γδ T cells, AML, Prevent recurrence
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to corporate strategic adjustment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Guangzhou Bio-gene Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 14 Aug 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 a prospective, double-arm, single-center, randomized controlled single-blind clinical study
Detailed description
This study is a prospective, single-center, two-arm, single-blind randomized controlled clinical trial to evaluate the safety and efficacy of γδ T cell infusion in preventing recurrence in patients with high-risk AML after allogeneic transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gamma-Delta T cell injection | Experimental | Biological: Gamma-Delta T cell injectionExperimental group: Received γδT infusion after high-risk AML allogene transplantation standard prophylactic treatment. |
| Standard prophylactic treatment | Other | Other: Standard prophylactic treatmentControl group: High-risk AML received only standard prophylactic treatment after allogeneic transplantation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients voluntarily sign informed consent and are expected to complete the follow-up examination and treatment of the study procedures;
- Age 18-65 years old (including cut-off value), gender is not limited;
- AML patients have one of the high-risk factors for recurrence after allogeneic hematopoietic stem cell transplantation;
- AML patients need to meet 30±5 days after the end of allogeneic transplant therapy;
- 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);
Key exclusion criteria (13 listed)
- 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;
- Patients have a severe allergic history;
- The patient has severe heart disease;
- The patient has severe respiratory system disease;
- Those with grade III~IV acute GVHD 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 |
|---|---|---|
| Gamma-Delta T cell injectionExperimental group: Peripheral intravenous infusion of γδ T cells | Biological | Gamma-Delta T cell injection |
| Standard prophylactic treatmentStandard prophylactic treatment | Other | Standard prophylactic treatment |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: Up to 12 months.
Count the Incidence of adverse events.
2 secondary outcomes
Levels of peripheral blood γδ T cells after infusion（PK）
Time frame: Up to 12 months.
Concentration of Cytokine after Infusion (PD)
Time frame: Up to 12 months.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
Related trials for Leukemia
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingObservational study
Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
Leukemia, Lymphoma
RecruitingPhase 2
Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia
RecruitingPhase 2
Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia
RecruitingPhase 2
Testing the Addition of Venetoclax or Gemtuzumab Ozogamicin (GO) to Usual Treatment Regimen (Cytarabine and Daunorubicin, "7+3") for Core Binding Factor Acute Myeloid Leukemia (CBF-AML) to Improve Response (A MYELOMATCH Treatment Trial)
Core Binding Factor Acute Myeloid Leukemia
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. This study is not recruiting at the moment.
Donghua Zhang, MD study director
Tongji Hospital
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Gamma-Delta T cell injection and Standard prophylactic treatment in people with Leukemia and Myeloid, run by Guangzhou Bio-gene Technology Co., Ltd.
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: withdrawn, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: Up to 12 months.). 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 28 May 2026.