A Single-arm, Open-label, Phase I/II Clinical Study of GT719 Injection for Recurrent/Refractory CD19 Positive Adult B-cell Malignancies
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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.
Locations
Other Locations
China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
RECRUITING
Tianjin
Contact Information
Primary
Dehui Zou
zoudehui@ihcams.ac.cn
+8613602100955
Time Frame
Start Date: 2025-04-18
Estimated Completion Date: 2028-04-17
Participants
Target number of participants: 46
Treatments
Experimental: GT719 Injection treatment group
GT719 Injection
Related Therapeutic Areas
Sponsors
Leads: Grit Biotechnology
Collaborators: Institute of Hematology & Blood Diseases Hospital, China