RecruitingPhase 1Phase 2NCT06948981

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

A Single-arm, Open-label, Phase I/II Clinical Study of GT719 Injection for Recurrent/Refractory CD19 Positive Adult B-cell Malignancies


Sponsor

Grit Biotechnology

Enrollment

46 participants

Start Date

Apr 18, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an experimental cell therapy called GT719 for adults with B-cell blood cancers (such as certain types of leukemia or lymphoma) that have come back or stopped responding to other treatments. GT719 is designed to target a protein called CD19 found on these cancer cells. **You may be eligible if...** - You are an adult diagnosed with a CD19-positive B-cell blood cancer - Your cancer has relapsed (come back) or is refractory (no longer responding to treatment) - You are in relatively good physical condition and can perform normal daily activities (ECOG score 0 or 1) - You are willing to follow the study protocol and provide informed consent **You may NOT be eligible if...** - You have a primary immune deficiency disorder - You have had a blood clot (deep vein thrombosis or pulmonary embolism) in the past 6 months requiring blood thinners - You have another medical condition that could interfere with the safety or effectiveness assessments of the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALGT719 Injection

GT719 Injection


Locations(1)

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

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NCT06948981


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