NCT06703892

A Study to Evaluate the Safety and Clinical Activity of GF- CART01 (CD20/19 CAR T Cell) in Subjects With Relapsed or Refractory B-Cell Hematological Malignancies

An Open-Label, Non-Randomized, Phase I, Prospective, Dose- Finding Study to Evaluate the Safety and Clinical Activity of GF- CART01 (CD20/19 CAR T Cell) in Subjects With Relapsed or Refractory B-Cell Hematological Malignancies

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: GenomeFrontier Therapeutics TW Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I, prospective, dose-finding study to evaluate the safety, persistence, and clinical activity of GF-CART01 in subjects aged 18-70 with relapsed or refractory (R/R) B-cell hematological malignancies and failure of two-line or more standard chemotherapies or auto-hematopoietic stem cell transplantation (HSCT).This study is a traditional 3+3 dose-escalation design to observe dose-limiting toxicity (DLT), establish the maximum tolerated dose(MTD)/recommended phase 2 doses (RP2D), and preliminary efficacy of GF-CART01. RP2D may equal to or lower than MTD

Conditions

• Diffuse Large B Cell Lymphoma Relapsed
• Diffuse Large B Cell Lymphoma Refractory
• Follicular Lymphoma ( FL)
• Primary Mediastinal Large B-Cell Lymphoma-Refractory
• Primary Mediastinal Large B-Cell Lymphoma-Recurrent
• High-grade B-cell Lymphoma (HGBCL)

Interventions

Type	Name	Description
BIOLOGICAL	GF-CART01	CAR positive viable T cells-Mid
BIOLOGICAL	GF-CART01	CAR positive viable T cells-High
BIOLOGICAL	GF-CART01	CAR positive viable T cells-Low

Timeline

• Start date: 2025-06-09
• Primary completion: 2027-03-01
• Completion: 2027-12-01
• First posted: 2024-11-25
• Last updated: 2025-12-22

Locations

1 site across 1 country: Taiwan