RecruitingEarly Phase 1NCT07131254

A Clinical Study Evaluating the Safety and Efficacy of GT719 Universal Cell Injection in Adult Participants With Relapsed/Refractory CD19-positive B-cell Malignant Hematological Tumors


Sponsor

Grit Biotechnology

Enrollment

34 participants

Start Date

Mar 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a prospective single-arm open-label 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 34 subjects 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 a new type of cell therapy called GT719 — made from donated immune cells — for people with aggressive blood cancers (B-cell leukemia or B-cell lymphoma) that have come back or stopped responding to treatment. **You may be eligible if...** - You are 18–75 years old - You have been diagnosed with relapsed or treatment-resistant B-cell acute lymphoblastic leukemia or B-cell lymphoma - Lab tests show your cancer cells carry a marker called CD19 - You are otherwise reasonably healthy and active (able to do light activity) - Your heart, kidneys, and liver are functioning adequately - At least 2 weeks have passed since your last cancer treatment **You may NOT be eligible if...** - Your cancer has spread to the brain, spinal fluid, or testicles - You have had another cancer in the past 5 years (some exceptions apply) - You had a stem cell transplant within the last 6 weeks - You have an active, uncontrolled infection - You are pregnant or unwilling to use contraception for 1 year after treatment 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)

Ganzhou City People's Hospital

Ganzhou, Jiangxi, China

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NCT07131254


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