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RECRUITING
NCT07910708
PHASE1

GN001 for Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma and B-Cell Acute Lymphoblastic Leukemia

Sponsor: Department of Hematology,Rheumatology and Immunology,Pu'er People's Hospital

View on ClinicalTrials.gov

Summary

This study will evaluate GN001 in adults aged 18 to 75 years with CD19-positive relapsed or refractory B-cell non-Hodgkin lymphoma or B-cell acute lymphoblastic leukemia. GN001 is an investigational lentiviral vector-based treatment designed to generate CD19-targeted chimeric antigen receptor (CAR) T cells within the body. The main purpose is to assess safety and tolerability at different doses. The study will also assess antitumor activity, the expansion and persistence of CAR T cells, and biological responses to treatment. Participants will receive GN001 by intravenous infusion. The study includes dose escalation and may include dose expansion after safety review. Long-term safety follow-up is planned.

Official title: An Exploratory Clinical Study of GN001 in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma and B-Cell Acute Lymphoblastic Leukemia

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2026-08-04

Completion Date

2029-08

Last Updated

2026-11-02

Healthy Volunteers

No

Interventions

BIOLOGICAL

GN001

GN001 administered as a single intravenous infusion.

Locations (2)

The 920th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army

Kunming, Yunnan, China

Pu'er People's Hospital

Pu'er, Yunnan, China