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).
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.
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.
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).
Grit Biotechnology
Lead sponsor
Shenzhen People's Hospital
Collaborator