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

NCT ID: NCT06948981

Last Updated: 2025-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-18

Study Completion Date

2028-04-17

Brief Summary

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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

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Conditions

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Hematological Malignancy (Leukemia- Lymphoma)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GT719 Injection treatment group

GT719 Injection

Group Type EXPERIMENTAL

GT719 Injection

Intervention Type BIOLOGICAL

GT719 Injection

Interventions

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GT719 Injection

GT719 Injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role collaborator

Grit Biotechnology

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dehui Zou

Role: CONTACT

+8613602100955

Facility Contacts

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Dehui Zou

Role: primary

+8613602100955

Other Identifiers

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GRIT-CD-CHN-719-001-056

Identifier Type: -

Identifier Source: org_study_id

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