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

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

Recruiting
18-75 years
All
Phase 1/2

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Overview

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

Inclusion Criteria:

  1. Voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol.

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  2. Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1.

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  3. CD19 positivity confirmed by flow cytometry and/or histopathology.

Exclusion Criteria:

  1. Primary immunodeficiency.

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  2. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment, requiring systemic anticoagulant therapy.

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  3. Any medical condition that may interfere with the evaluation of the safety or effectiveness of research and treatment;

Study details
    Hematological Malignancy (Leukemia- Lymphoma)

NCT06948981

Grit Biotechnology

15 October 2025

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FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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