RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: Grit Biotechnology • ClinicalTrials.gov ID: NCT06948981

Registry updated: 2026-09-18

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Description

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.

Interventions

GT719 Injection (Biological)
GT719 Injection

Eligibility criteria

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;

Conditions

Hematological Malignancy (Leukemia- Lymphoma)

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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