GT719 Injection for the Treatment of Recurrent/Refractory CD19 Positive Adult B-cell Malignancies
About this study
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.
- Condition
- Hematological Malignancy (Leukemia- Lymphoma)
- Tested
- GT719 Injection
- Sponsor
- Grit Biotechnology
Who can join
- Age
- 18 to 75 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 6
- Minimum age: 18 years
- Maximum age: 75 years
- Study condition: Hematological Malignancy (Leukemia- Lymphoma)
- Voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol.
- Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1.
- CD19 positivity confirmed by flow cytometry and/or histopathology.
Exclusion 3
- Primary immunodeficiency.
- History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment, requiring systemic anticoagulant therapy.
- Any medical condition that may interfere with the evaluation of the safety or effectiveness of research and treatment;
Where
1 site, 1 recruiting
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
Contact
-
Dehui Zou
+8613602100955 zoudehui@ihcams.ac.cn
Potential match only. Final eligibility is determined by the study team.