Status:
RECRUITING
GT719 Injection for the Treatment of Recurrent/Refractory CD19 Positive Adult B-cell Malignancies
Lead Sponsor:
Grit Biotechnology
Collaborating Sponsors:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Hematological Malignancy (Leukemia- Lymphoma)
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief 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 GT7...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
April 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 17 2028
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06948981
Start Date
April 18 2025
End Date
April 17 2028
Last Update
September 16 2025
Active Locations (1)
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1
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China