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

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

NCT Number	NCT06703892
Lead Sponsor	GenomeFrontier Therapeutics TW Co., Ltd.
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)
Enrollment	18 participants
Start Date	2025-06-09
Primary Completion	2027-03 (estimated)
Study Completion	2027-12 (estimated)
Updated on ClinicalTrials.gov	2026-06-12