Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
NCT06948981

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

Led by Grit Biotechnology · Updated on 2025-09-16

46

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

Sponsors

G

Grit Biotechnology

Lead Sponsor

I

Institute of Hematology & Blood Diseases Hospital, China

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntarily enrolled in the study, signed informed consent, and willing to follow the study plan
  • Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1
  • Confirmed CD19 positivity by flow cytometry or histopathology
Not Eligible

You will not qualify if you...

  • Primary immunodeficiency
  • Symptomatic deep vein thrombosis or pulmonary embolism within 6 months before enrollment requiring anticoagulant therapy
  • Any medical condition that could interfere with evaluating safety or treatment effectiveness

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Tianjin, Tianjin Municipality, China

Actively Recruiting

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Research Team

D

Dehui Zou

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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