A Clinical Study Evaluating the Safety and Efficacy of GT719 Universal Cell Injection in Adult Participants With Relapsed/Refractory CD19-positive B-cell Malignant Hematological Tumors
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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\. For any prior systemic therapy (excluding immune checkpoint inhibitors), at least 2 weeks or 5 half-lives (whichever is shorter) must have elapsed before the participant is scheduled to receive the study treatment. For any prior treatment with immune checkpoint inhibitors (such as anti-PD-1 or anti-PD-L1 monoclonal antibodies like Pembrolizumab, OX40 agonists, 4-1BB agonists, etc.), at least 3 half-lives or 28 days (which