Menu
Recruiting NCT06948981

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

Phase I / Phase II Interventional Hematological Malignancy (Leukemia- Lymphoma)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GT719 Injection.
Who it may be relevant to
Registry conditions: Hematological Malignancy (Leukemia- Lymphoma). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Biological GT719 Injection
    GT719 Injection

Primary outcome measures

  • Incidence and severity of adverse events per CTCAE 5.0 [Time frame: From infusion to the end of the treatment at 12 months]
Secondary outcome measures (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]

Eligibility criteria

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences — Tianjin

Identifiers

NCT: NCT06948981 · GRIT-CD-CHN-719-001-056

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗