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Relapsed/Refractory Acute Myeloid Leukemia (AML)Early Phase 1NCT07676006

A Clinical Study to Investigate the Safety and Efficacy of Off-the-Shelf iNKT Cell Injection Targeting CD33/CD70 in Adult Patients With Relapsed/Refractory Acute Myeloid Leukemia

A Early Phase 1 study testing GT737 Injection in people with Relapsed/Refractory Acute Myeloid Leukemia (AML), run by Grit Biotechnology at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This is a single-arm, open-label, dose-escalation, prospective exploratory clinical study intended to evaluate the safety, efficacy and cellular pharmacokinetics of GT737 cells in adult patients with relapsed/refractory acute myeloid leukemia (AML). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
GT737 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteChina
Study dates
May 2027to Jun 2030
Phase
Early Phase 1
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Voluntarily participate in this clinical study, fully understand the study content, sign the informed consent form, and be willing to comply with all study procedures and complete all follow-up visits.
  • 2. Aged between 18 and 75 years old (inclusive), with no restriction on gender.
  • 3. Confirmed diagnosis of relapsed/refractory acute myeloid leukemia (AML) per the 2016 WHO Classification, with the specific definitions as follows:
  • Confirmed AML with bone marrow blasts ≥5% at screening, and meeting any one of the following criteria:
  • Relapsed disease: Relapse after achieving complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) following standard induction chemotherapy;
  • Refractory disease: a) Failure to achieve CR/CRi after 2 cycles of induction chemotherapy; b) Relapse within 12 months of first remission with no response to subsequent re-treatment; c) Relapse after autologous or allogeneic hematopoietic stem cell transplantation; d) Failure to achieve CR/CRi after at least two lines of salvage therapy.
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  • 4. Confirmed positive expression of CD33 or CD70 via flow cytometry and/or immunohistochemistry.
  • 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • 6. Estimated survival of more than 12 weeks.
  • 7. Toxicities resulting from prior therapies must be stabilized and recovered to Grade ≤1 (alopecia and other toxicities with no significant clinical impact are excluded).
  • 8. Adequate hepatic, renal, pulmonary and cardiac function, meeting the following specific criteria:
  • o Estimated creatinine clearance (calculated via the Cockcroft-Gault formula) ≥60 mL/min;
  • o Serum alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≤2.5 times the upper limit of normal (ULN);
  • o Total bilirubin ≤1.5 mg/dL (participants with Gilbert's syndrome excluded from this criterion);
  • o Cardiac ejection fraction ≥50%, no evidence of pleural effusion on echocardiogram (ECHO), and no clinically significant abnormalities on electrocardiogram (ECG);
  • o Absence of clinically significant pleural effusion;
  • o Baseline oxygen saturation >92% while breathing room air.
  • 9. Females of childbearing potential: Serum or urine pregnancy test negative at screening (subjects with surgical sterilization or menopause for ≥2 years are not considered of childbearing potential). Must agree to use highly effective and reliable contraception for 1 year after receiving study treatment, and refrain from oocyte donation.
  • 10. Male participants: If sexually active with females of childbearing potential, must agree to use highly effective and reliable contraception for 1 year after receiving study treatment, and refrain from sperm donation.

Who cannot join

  • 1. Prior history of central nervous system (CNS) leukemia; or intracranial magnetic resonance imaging (MRI)/PET-CT at screening suggestive of CNS leukemia; or malignant cells identified in cerebrospinal fluid (CSF).
  • 2. Other untreated malignant neoplasms diagnosed within the past 5 years or concurrent malignancies (Exceptions: adequately treated cervical carcinoma in situ, localized cutaneous squamous cell carcinoma, basal cell carcinoma, localized prostate cancer, ductal carcinoma in situ of the breast, urothelial carcinoma ≤T1; participants with prostate cancer under active surveillance are eligible).
  • 3. Prior receipt of CD33- or CD70-targeted cellular therapies including CAR-T, NK or iNKT cells (Excluding subjects previously treated with GT737 who qualify for re-treatment).
  • 4. Systemic corticosteroids administered within 7 days prior to cell infusion (Exceptions: inhaled corticosteroids and subjects with prior allogeneic transplantation history).
  • 5. History of hypersensitivity to any component of investigational products to be used in this study, including but not limited to GT737 cell infusion product, cyclophosphamide and fludarabine.
  • 6. Uncontrolled suspected or confirmed fungal, bacterial, viral or other infections, or infections requiring intravenous (IV) antimicrobial therapy (Excluding prophylactic antimicrobial treatment).
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  • 7. Positive test results for any of the following: human immunodeficiency virus (HIV) antibody, Treponema pallidum antibody, cytomegalovirus IgM (CMV-IgM), Epstein-Barr virus IgM (EBV-IgM).
  • 8. Active hepatitis B (positive HBV-DNA) and/or active hepatitis C (positive HCV RNA).
  • Participants positive for HBsAg/HBcAb must undergo HBV-DNA testing; those with negative HBV-DNA may be enrolled. Post-enrollment, prophylactic antiviral therapy shall be administered if clinically indicated per investigator assessment.
  • Subjects with negative HCV antibody are eligible for enrollment. Participants with positive HCV antibody must receive HCV RNA testing and may be enrolled only if HCV RNA is negative.
  • 9. Presence of any indwelling line or drainage tube (Exceptions: dedicated central venous access catheters such as Port-a-Cath and Hickman catheter).
  • 10. Current or prior central nervous system disorders including seizures, cerebral ischemic/hemorrhagic events, dementia, cerebellar disease, or any autoimmune disease involving the CNS.
  • 11. Cardiac involvement secondary to acute myeloid leukemia.
  • 12. Occurrence of any of the following within 6 months prior to signing the informed consent form:
  • Uncontrolled congestive heart failure (New York Heart Association Class III-IV), angina pectoris, myocardial infarction, cardiomyopathy;
  • Stroke (Excluding lacunar infarction), coronary or peripheral artery bypass graft surgery;
  • Clinically significant arrhythmias (e.g., ventricular arrhythmia), markedly prolonged QT interval (corrected QTc ≥500 ms by Bazett's formula, as judged by the investigator);
  • Uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg), uncontrolled diabetes mellitus;
  • Pulmonary embolism, diffuse pulmonary infiltrates, impaired pulmonary function;
  • Other medical conditions deemed unsuitable for study participation by the investigator.
  • 13. Anticipated or potential need for emergency treatment within 6 weeks due to ongoing or imminent oncologic emergencies (e.g., tumor mass effect, tumor lysis syndrome).
  • 14. Primary immunodeficiency disorders.
  • 15. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months before enrollment requiring systemic anticoagulation therapy.
  • 16. Any medical condition that may interfere with the assessment of safety or efficacy of the study treatment.
  • 17. Live attenuated vaccines or mRNA vaccines administered within 8 weeks prior to lymphodepleting conditioning; inactivated vaccines administered within 4 weeks prior to lymphodepleting conditioning.
  • 18. Females of childbearing potential who are pregnant or breastfeeding (Subjects with surgical sterilization or menopause for ≥2 years are not regarded as of childbearing potential).
  • 19. Male or female participants unwilling to use contraceptive measures from the time of informed consent through 6 months after completion of study treatment.
  • 20. Participants judged by the investigator to be unlikely to complete all study visits and procedures (including follow-up) or unable to comply with study participation requirements.
  • 21. History of autoimmune disease within the past 2 years causing end-organ damage or requiring systemic immunosuppressive agents/systemic disease-modifying therapy (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, etc.).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jihao Zhou contact

+86 15000901110

zhoujihao@aliyun.com

China1 site

  • Shenzhen People's Hospital

    Shenzhen, Guangdong, 450018

    Jihao Zhou, +86 15000901110, zhoujihao@aliyun.com

    Jihao Zhou

Other trials in China

About this study

This is a single-arm, open-label, dose-escalation, prospective exploratory clinical study intended to evaluate the safety, efficacy and cellular pharmacokinetics of GT737 cells in adult patients with relapsed/refractory acute myeloid leukemia (AML).

Being tested
GT737 Injection
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GT737 InjectionBiological

    GT737 Injection

Study groups in NCT07676006
Study groupRoleWhat they receive
GT737 Injection treatment groupExperimentalGT737 Injection
Receives: Biological: GT737 Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants experiencing dose limiting toxicity

    The proportion of participants with dose-limiting toxicity (DLT) occurring within 28 days after infusion

    Measured: 28 days

  2. Adverse Events (AEs) occurring after infusion and their proportions

    Adverse Events (AEs) occurring after infusion and their proportions

    Measured: 28 days

  3. Severity of Adverse Events (AEs) after infusion

    Assess the severity of Adverse Events (AEs) within 28 days after infusion

    Measured: 28 days

  4. Compare the differences in safety and tolerability between different treatment subgroups (monotherapy and combination with sirolimus).

    Difference in the incidence and severity of DLT among different treatment subgroups (monotherapy and combination with sirolimus)

    Measured: 28 Days

Secondary outcomes (8)

  1. Pharmacokinetic parameters: Time to peak expansion （Tmax）after GT737 infusion

    Monitor the time to peak expansion （Tmax）after GT737 infusion.

    Measured: 28 Days

  2. Pharmacokinetic parameters: peak expansion（Cmax） after GT737 infusion

    Monitor the peak expansion（Cmax） after GT737 infusion.

    Measured: 28 Days

  3. Pharmacokinetic parameters: area under the curve (AUC) after GT737 infusion

    Monitor the area under the curve (AUC) after GT737 infusion.

    Measured: 28 Days

  4. Pharmacokinetic parameters: survival duration after GT737 infusion

    Monitor the survival duration after GT737 infusion.

    Measured: 12 months after infusion

  5. Pharmacokinetic parameters: differences in Time to peak expansion （Tmax）of GT737 cells across different treatment subgroups

    Assess the differences in Time to peak expansion （Tmax）of GT737 cells across different treatment subgroups

    Measured: 28 Days

  6. Pharmacokinetic parameters: differences in peak expansion（Cmax）of GT737 cells across different treatment subgroups

    Assess the differences in peak expansion（Cmax）of GT737 cells across different treatment subgroups

    Measured: 28 Days

  7. Pharmacokinetic parameters: differences in area under the curve (AUC) of GT737 cells across different treatment subgroups

    Assess the differences in area under the curve (AUC) of GT737 cells across different treatment subgroups

    Measured: 28 Days

  8. Pharmacokinetic parameters: differences in survival duration of GT737 cells across different treatment subgroups

    Assess the differences in survival duration of GT737 cells across different treatment subgroups

    Measured: 12 months after infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2026
  2. Study startMay 2027 (estimated)
  3. Primary completionJun 2030 (estimated)
  4. Study completionJun 2030 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07676006
Sponsor's protocol ID
GRIT-CD-IIT-737-001-001
Status last verified
Sep 2026
First submitted
22 Jun 2026
Last updated
11 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing GT737 Injection in people with Relapsed/Refractory Acute Myeloid Leukemia (AML), run by Grit Biotechnology 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 19 inclusion and 29 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: opening soon, as of the sponsor's last update on 11 Sep 2026. 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.

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?

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 Jihao Zhou (+86 15000901110, zhoujihao@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants experiencing dose limiting toxicity (time frame: 28 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07676006.

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 11 Sep 2026.

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