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

Phase 1

Recruiting

• Conditions: Hematological Malignancy (Leukemia- Lymphoma)
• Interventions: Biological: GT719 Injection

• Registration Number: NCT06948981
• Lead Sponsor: Grit Biotechnology

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-04-18
• Study First Submitted: 2025-04-22
• Study First Submitted QC: 2025-04-22
• Study First Posted: 2025-04-29
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-10
• Last Update Posted: 2025-09-16
• Primary Completion: 2028-04-17
• Study Completion: 2028-04-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GT719 Injection treatment group	GT719 Injection	GT719 Injection

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events per CTCAE 5.0	From infusion to the end of the treatment at 12 months	To characterize the safety profile of GT719 in patients with recurrent/refractory CD19 positive adult B-cell malignant hematological tumor as measured by the incidence and severity of adverse events per CTCAE 5.0

Secondary Outcome Measures

Name	Time	Method
Objective response rate	28 days post the first infusion, and follow-ups at Month 2, Month 3, Month 6, Month 9 and Month 12	To evaluate efficacy parameters such as objective response rate(ORR) assessed by the Investigator

Trial Locations

Locations (1)

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Tianjin, Tianjin Municipality, China