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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

GF-CART01
Biological/Vaccine
CAR positive viable T cells-Mid
GF-CART01
Biological/Vaccine
CAR positive viable T cells-High
GF-CART01
Biological/Vaccine
CAR positive viable T cells-Low

Treatment groups

18 Participants

are divided into 1 treatment group

Group A: GF-CART01Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Maximum tolerated dose (MTD)

Percentage of subjects with dose-limiting toxicity (DLT) from Visit 4 (Day 1) to Visit 9 (Day 29) after GF-CART01 cell infusion

Time frame

From Day 1 to 28 days after cell infusion

Safety and tolerability of GF-CART01

Percentage of subjects with treatment-emergent adverse events (TEAEs), ≥ grade 3 TEAEs, serious adverse events (SAEs), adverse events of special interest (AESIs)

Time frame