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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol.
\-
2. Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1.
\-
3. CD19 positivity confirmed by flow cytometry and/or histopathology.
Exclusion Criteria:
1. Primary immunodeficiency.
\-
2. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment, requiring systemic anticoagulant therapy.
\-
3. Any medical condition that may interfere with the evaluation of the safety or effectiveness of research and treatment;
Primary outcome measure(s)
Incidence and severity of adverse events per CTCAE 5.0 — From infusion to the end of the treatment at 12 months To characterize the safety profile of GT719 in patients with recurrent/refractory CD19 positive adult B-cell malignant hematological tumor as measured by the incidence and severity of adverse events per CTCAE 5.0
Trial sites (1)
Facility
City
Region
Status
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.