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

NCT06948981 | Recruiting Phase 1

• 1 other identifier: GRIT-CD-CHN-719-001-056
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematological Malignancy (Leukemia- Lymphoma)

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events per CTCAE 5.0

  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

  From infusion to the end of the treatment at 12 months

Secondary Outcomes (1)

• Objective response rate

  28 days post the first infusion, and follow-ups at Month 2, Month 3, Month 6, Month 9 and Month 12

Study Arms (1)

GT719 Injection treatment group

EXPERIMENTAL

GT719 Injection

Biological: GT719 Injection

Interventions

GT719 Injection BIOLOGICAL

GT719 Injection

GT719 Injection treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol.
• Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1.
• CD19 positivity confirmed by flow cytometry and/or histopathology.

You may not qualify if:

• Primary immunodeficiency.
• History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment, requiring systemic anticoagulant therapy.
• Any medical condition that may interfere with the evaluation of the safety or effectiveness of research and treatment;

Sponsors & Collaborators

• Grit Biotechnology: lead
• Institute of Hematology & Blood Diseases Hospital, China: collaborator

Study Sites (1)

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

Tianjin, Tianjin Municipality, China

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Dehui Zou

CONTACT

+8613602100955; zoudehui@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 29, 2025
• Study Start: April 18, 2025
• Primary Completion (Estimated): April 17, 2028
• Study Completion (Estimated): April 17, 2028
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)