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

ConditionsDiffuse 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)

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-70

SponsorGenomeFrontier Therapeutics TW Co., Ltd.

About this trial

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

Eligibility criteria

Qualifiers

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 Mediastinal Large B-cell Lymphoma (PMBCL), or High-Grade B-Cell Lymphoma (HGBCL) per the world health organization (WHO) Classification Criteria for Lymphoma (2022)

Tumor cell surface expression of CD19 (+) and/or CD20 (+) by flow cytometry or immunohistochemistry staining

Disqualifiers

Previously treated with any CAR T cell product or allogenic hematopoietic stem cell transplant (HSCT)

Known or suspected allergy, hypersensitivity, or intolerance to any ingredients of the investigational product (IP)

Known medical history or possible risk for taking contrast agent(s) for positron emission tomography (PET) and/or computed tomography (CT) scan

Received any other investigational product, cell therapy, or gene therapy within 12 weeks prior to the leukapheresis

Trial design

Treatments tested in this trial

GF-CART01
GF-CART01
GF-CART01

Treatment groups

18 Participants

are divided into 1 treatment group

Locations

National Taiwan University Hospital Taipei Taiwan

Sponsors and collaborators

GenomeFrontier Therapeutics TW Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov