RecruitingPhase 1Phase 2NCT06948981
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
Sponsor
Grit Biotechnology
Enrollment
46 participants
Start Date
Apr 18, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria5
- 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 Criteria5
- 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;
Interventions
BIOLOGICALGT719 Injection
GT719 Injection
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06948981