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Clinical Trials in China / NCT06948981
Recruiting Phase 1/2

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

NCT06948981 · tracked via the Priya Life Science China tracker
Sponsor
Grit Biotechnology
Phase
Phase 1/2
Started
2025-04-18
Last updated
2026-09-18

Condition(s) studied

Hematological Malignancy (Leukemia- Lymphoma)

Investigational drug(s) / intervention(s)

GT719 Injection →

GT719 Injection: GT719 Injection

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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;

Primary outcome measure(s)

  • Incidence and severity of adverse events per CTCAE 5.0 — 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

Trial sites (1)

FacilityCityRegionStatus
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences Tianjin Tianjin Municipality Recruiting

More Grit Biotechnology trials in China

GT719 Injection for Recurrent/Refractory Antibody-mediated Neurological Immune Diseases Recruiting
IB-T101 Injection for Treatment of Patients With Advanced Clear Cell Renal Cell Carcinoma Recruiting
GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors Recruiting
A Clinical Study Evaluating the Safety and Efficacy of GT729 Universal Cell Injection in the Treatment of Refractory or Relapsed Chronic Graft-versus-host Disease (cGVHD) Recruiting
Autologous Tumor-Infiltrating Lymphocyte (GT307) for Treatment of Patients With Solid Tumours Recruiting

Other trials for the same condition

A Clinical Study Evaluating the Safety and Efficacy of GT719 Universal Cell Injection in Adult Participants With Relapsed/Refractory CD19-positive B-cell Malignant Hematological Tumors Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06948981 on ClinicalTrials.gov ↗ ← All trials in China