Clinical Study of GT719 Injection for Recurrent/Refractory CD19 Positive Adult B-cell Malignancies

Grit Biotechnology

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Hematological Malignancy (Leukemia- Lymphoma)

Treatments: Biological: GT719 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06948981

GRIT-CD-CHN-719-001-056

Details and patient eligibility

About

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 34 subjects will be enrolled in this study.

Enrollment: 34 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

GT719 Injection treatment group

Experimental group

Description:

GT719 Injection

Treatment:

Biological: GT719 Injection