Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06948981

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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

Tianjin, Tianjin Municipality, China

Location status: Recruiting

Location contact

Dehui Zou

CONTACT

[email protected]

+8613602100955

Dehui Zou

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;

Treatment and study plan

GT719 Injection

Biological

GT719 Injection

Primary outcomes

  1. Incidence and severity of adverse events per CTCAE 5.0

    Time frame: 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 outcomes

  1. Objective response rate

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Grit Biotechnology

Industry

Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China

Registry information

Official study title

A Single-arm, Open-label, Phase I/II Clinical Study of GT719 Injection for Recurrent/Refractory CD19 Positive Adult B-cell Malignancies

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 29, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.