Overview
This study is a prospective single-arm open-labled 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 46 subjects (anticipated) will be enrolled in this study.
Eligibility
Inclusion Criteria:
- Voluntarily enrolled in the study, signed an informed consent form, and willing and
able to comply with the study protocol.
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- Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1.
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- CD19 positivity confirmed by flow cytometry and/or histopathology.
Exclusion Criteria:
- Primary immunodeficiency.
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- History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months
prior to enrollment, requiring systemic anticoagulant therapy.
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- Any medical condition that may interfere with the evaluation of the safety or effectiveness of research and treatment;