A Single-arm, Open-label, Phase I/II Clinical Study of GT719 Injection for Recurrent/Refractory CD19 Positive Adult B-cell Malignancies
This study is a prospective single-arm open-label phase I/II 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.
• 5\. Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1.
• 6\. Expected survival period \> 12 weeks;
• 7\. The results of laboratory tests during the screening period indicate that the subject has appropriate organ function.
• 8\. Women and men of childbearing potential should be willing to use highly effective and reliable contraceptive methods for 1 year after receiving the study treatment, and are absolutely prohibited from donating eggs within 1 year after receiving the study treatment infusion during the study period.