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

Trial Details

NCT ID
NCT06703892
Phase
PHASE1
Sponsor
GenomeFrontier Therapeutics TW Co., Ltd.
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • GF-CART01
Locations (sample)
  • Taipei, Taiwan|25.05306,121.52639

Key Eligibility Criteria

  • Subjects must be of age ≥ 18 years and ≤ 70 years
  • Subjects or their legal guardians must volunteer to participate in the study and sign the informed consent
  • Histologically confirmed diagnosis of Diffuse Large B-Cell Lymphoma - Not Otherwise Specified (DLBCL-NOS), follicular lymphoma (FL), Primary Medias…
  • Tumor cell surface expression of CD19 (+) and/or CD20 (+) by flow cytometry or immunohistochemistry staining

For full eligibility, visit ClinicalTrials.gov.

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