This study is a prospective single-arm open-label clinical trial, including dose escalation and expansion phase, aims to evaluate the safety, efficacy, and cellular pharmacokinetics of GT719 Injection in relapsed/refractory CD19 positive adult B-cell non Hodgkin lymphoma (B-NHL) and B-acute lymphoblastic leukemia (B-ALL) patients. A total of 34 subjects will be enrolled in this study.
1. Voluntarily enrolled in the study, signed an informed consent form, willing and able to comply with the study protocol.
2. Aged 18 to 75 years (inclusive), regardless of gender.
3. Participants with refractory or relapsed acute B-cell lymphoblastic leukemia or B-cell lymphoma diagnosed according to the WHO 2016 classification.
4. CD19 positivity confirmed by flow cytometry and/or histopathology.
1. Participants with a history of central nervous system (CNS) leukemia/lymphoma, or those with CNS leukemia/lymphoma shown by magnetic resonance imaging (MRI) or positron emission tomography-computed tomography (PET-CT) intracranial imaging during the screening period, or those with detected malignant cells in cerebrospinal fluid or brain metastases.
2. History of testicular leukemia/lymphoma, and imaging examinations during the screening period suggest active testicular leukemia/lymphoma.
3. History of other untreated malignant tumors within the past 5 years or concurrent with the current disease, excluding adequately treated carcinoma in situ of the cervix, localized cutaneous squamous cell carcinoma, basal cell carcinoma, localized prostate cancer, ductal carcinoma in situ of the breast, or ≤T1 urothelial carcinoma. Participants with prostate cancer undergoing active surveillance are eligible for this study;
4. Hematopoietic stem cell transplantation with curative intent performed within 6 weeks prior to the planned infusion of GT719 cells;
Single group
GT719 Injection
Biological/VaccineGT719 Injection
Incidence and severity of adverse events (AEs)
Incidence and severity of Adverse events (AEs) occurring after infusion and their proportion
Proportion of participants experiencing dose limiting toxicity
Proportion of participants experiencing dose limiting toxicity (DLT) within 28 days after cell infusion
overall response rate (ORR)
3 months overall response rate (ORR)
Best Overall Response（BOR）
3 months Best Overall Response（BOR）
Duration of Response（DOR）
3 months Duration of Response（DOR）
Progression-Free Survival（PFS）
3 months Progression-Free Survival（PFS）
Peripheral white blood cell count
The measured total count of white blood cells in peripheral blood
Changes in peripheral white blood cell differential
The dynamic changes in the quantity and proportion of various types of white blood cells in peripheral blood over time
Phenotypic changes of GT719 cells and other NKT cells
Detect the dynamic changes in cell surface marker expression, morphological characteristics and function-related phenotypic features of GT719 cells and other natural killer T (NKT) cells
Changes in inflammatory factors in peripheral blood over different treatment time periods
Dynamically monitor the concentration fluctuations of various inflammatory factors in peripheral blood during different treatment time periods
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Grit Biotechnology
Lead sponsor
Ganzhou City People's Hospital
Collaborator
