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

NCT06703892 Phase 1 RECRUITING

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

Details

Lead sponsor	GenomeFrontier Therapeutics TW Co., Ltd.
Phase	Phase 1
Status	RECRUITING
Enrolment	18
Start date	2025-06-09
Completion	2027-12

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

• GF-CART01
• GF-CART01
• GF-CART01

Primary outcomes

• Maximum tolerated dose (MTD) — From Day 1 to 28 days after cell infusion
  Percentage of subjects with dose-limiting toxicity (DLT) from Visit 4 (Day 1) to Visit 9 (Day 29) after GF-CART01 cell infusion
• Safety and tolerability of GF-CART01 — From Day 1 to 1 year after cell infusion
  Percentage of subjects with treatment-emergent adverse events (TEAEs), ≥ grade 3 TEAEs, serious adverse events (SAEs), adverse events of special interest (AESIs)

Countries

Taiwan