GT719 Injection for the Treatment of Recurrent/Refractory CD19 Positive Adult B-cell Malignancies

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-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.

Inclusion Criteria:

1. Voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol.

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2. Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1.

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3. CD19 positivity confirmed by flow cytometry and/or histopathology.

Exclusion Criteria:

1. Primary immunodeficiency.

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2. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment, requiring systemic anticoagulant therapy.

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3. Any medical condition that may interfere with the evaluation of the safety or effectiveness of research and treatment;