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Recruiting
NCT06948981
GT719 Injection for the Treatment of Recurrent/Refractory CD19 Positive Adult B-cell Malignancies
Conditions: Hematological Malignancy (Leukemia- Lymphoma)
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 46
Sponsor: Grit Biotechnology
Location: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences Tianjin Tianjin Municipality
Summary
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 Criteria
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;
Source: ClinicalTrials.gov (NCT06948981). StuddyBuddy aggregates publicly available trial information.