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

NCT07676006 | Not Yet Recruiting Early Phase 1

• 1 other identifier: GRIT-CD-IIT-737-001-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Relapsed/Refractory Acute Myeloid Leukemia (AML)

Outcome Measures

Primary Outcomes (4)

• Proportion of participants experiencing dose limiting toxicity

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

  28 days

• Adverse Events (AEs) occurring after infusion and their proportions

  Adverse Events (AEs) occurring after infusion and their proportions

  28 days

• Severity of Adverse Events (AEs) after infusion

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

  28 days

• 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)

  28 Days

Secondary Outcomes (8)

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

  28 Days

• Pharmacokinetic parameters: peak expansion（Cmax） after GT737 infusion

  28 Days

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

  28 Days

• Pharmacokinetic parameters: survival duration after GT737 infusion

  12 months after infusion

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

  28 Days

Study Arms (1)

GT737 Injection treatment group

EXPERIMENTAL

GT737 Injection

Biological: GT737 Injection

Interventions

GT737 Injection BIOLOGICAL

GT737 Injection

GT737 Injection treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. Aged between 18 and 75 years old (inclusive), with no restriction on gender.
• \. 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.
• \. Confirmed positive expression of CD33 or CD70 via flow cytometry and/or immunohistochemistry.
• \. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• \. Estimated survival of more than 12 weeks.
• \. Toxicities resulting from prior therapies must be stabilized and recovered to Grade ≤1 (alopecia and other toxicities with no significant clinical impact are excluded).
• \. 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);

You may not qualify if:

• \. 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).
• \. 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).
• \. 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).
• \. Systemic corticosteroids administered within 7 days prior to cell infusion (Exceptions: inhaled corticosteroids and subjects with prior allogeneic transplantation history).
• \. 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.
• \. Uncontrolled suspected or confirmed fungal, bacterial, viral or other infections, or infections requiring intravenous (IV) antimicrobial therapy (Excluding prophylactic antimicrobial treatment).
• \. 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).
• \. 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.
• \. Presence of any indwelling line or drainage tube (Exceptions: dedicated central venous access catheters such as Port-a-Cath and Hickman catheter).
• \. Current or prior central nervous system disorders including seizures, cerebral ischemic/hemorrhagic events, dementia, cerebellar disease, or any autoimmune disease involving the CNS.
• \. Cardiac involvement secondary to acute myeloid leukemia.
• \. 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;

Sponsors & Collaborators

• Grit Biotechnology: lead
• Shenzhen People's Hospital: collaborator

Study Sites (1)

Shenzhen People's Hospital

Shenzhen, Guangdong, 450018, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Jihao Zhou

CONTACT

+86 15000901110; zhoujihao@aliyun.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 30, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)