GT719 Injection for the Treatment of Recurrent/Refractory CD19 Positive Adult B-cell Malignancies

Recruiting now · Phase 1/Phase 2

Conditions studied: Hematological Malignancy (Leukemia- Lymphoma)

In brief

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.

Key facts

Study ID

NCT06948981

Run by

Grit Biotechnology

People needed

46

Starts

2025-04-18

Expected to finish

2028-04-17

Last updated by the study team

2025-09-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences — Tianjin, Tianjin Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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