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;
Grit Biotechnology
Lead sponsor
Ganzhou City People's Hospital
Collaborator