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

NCT06703892 | Recruiting Phase 1 DMC

• 1 other identifier: GF-01-01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

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)

Keywords

CAR T

Outcome Measures

Primary Outcomes (2)

• 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

  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)

  From Day 1 to 1 year after cell infusion

Secondary Outcomes (9)

• Preliminary efficacy of GF-CART01-ORR

  From Day 1 to 1 year after cell infusion

• Preliminary efficacy of GF-CART01-DOR

  From Day 1 to 1 year after cell infusion

• Pharmacokinetics of GF- CART01-Cmax

  From Day 1 to 1 year after cell infusion

• Pharmacokinetics of GF- CART01-Tmax

  From Day 1 to 1 year after cell infusion

• Pharmacokinetics of GF- CART01-pAUC

  From Day 1 to 1 year after cell infusion

Other Outcomes (1)

• Concentration of cytokines in peripheral blood

  From Day 1 to 1 year after cell infusion

Study Arms (1)

GF-CART01

EXPERIMENTAL

CAR-positive viable T cells

Biological: GF-CART01

Interventions

GF-CART01 BIOLOGICAL

CAR positive viable T cells-Mid

GF-CART01

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Relapsed, progressive or refractory disease (defined as have not achieved a complete response) after ≥ two lines of systemic therapy, including anti-CD20 antibody and anthracycline and/or Relapsed, progressive or refractory disease ( defined as have not achieved a complete response) after auto-HSCT
• Subjects have any accessible PET-positive lesion or measurable CT-positive lesion per Lugano 2014 criteria
• Adequate hematologic function: absolute neutrophil count (ANC) \> 1,000/μL, absolute lymphocyte count (ALC) \> 300/μL, platelet count ≥ 75,000/μL, hemoglobin ≥ 8.0 g/dL
• Adequate hepatic function: alanine aminotransferase (ALT) ≤ 5 times upper limit of normal (ULN), aspartate transaminase (AST) ≤ 5 times ULN, total bilirubin ≤ 1.5 times ULN
• Adequate renal function: blood estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m2 (calculated by Modification of Diet in Renal Disease (MDRD) equation)
• Adequate cardiac function: echocardiogram or multigated blood pool analysis (MUGA) shows left ventricular ejection fraction (LVEF) ≥ 50%; and no clinically significant electrocardiogram (ECG) findings
• Adequate pulmonary function: no active infection in the lungs, blood oxygen saturation in indoor air ≥ 92%
• No clinically significant pleural effusion determined by the investigators
• Estimated survival time ≥ 3 months
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
• Willingness and ability to comply with protocol-stated requirements, instructions, and restrictions in the investigator's judgement

You may not qualify if:

• 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
• Received any tyrosine kinase inhibitor within 2 weeks prior to the leukapheresis
• Received any systemic steroid, immunotherapy (such as immune checkpoint inhibitors, T- cell transfer therapies, monoclonal antibodies), or chemotherapy within 4 weeks prior to the leukapheresis
• Received any live vaccine from 2 weeks prior to the leukapheresis
• Subjects with human immunodeficiency virus (HIV), syphilis, Hepatitis B or C infection: HIV-1 and HIV-2 antibody positive, syphilis antibody positive, both hepatitis B virus (HBV) DNA and hepatitis B core (HBc) antibody positive, or hepatitis C virus (HCV) antibody positive
• Subjects with atrial or ventricular involvement by B-cell malignancies
• Subjects with tumor mass requiring urgent treatment within 8 weeks prior to the leukapheresis, such as ileus, tumor lysis syndrome, or vascular compression
• Subjects with severe disease or other uncontrolled diseases, such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia (urgent intervention indicated, life- threatening consequences, or hemodynamic compromise), cardiac angioplasty or stenting, unstable angina, cerebral thrombosis, cerebral hemorrhage, hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg)
• Unstable pulmonary embolism, deep venous embolism, or other major arterial/venous thromboembolism events that occurred within 6 weeks prior to the leukapheresis. If subjects receive anticoagulant therapy, the treatment dose and frequency must be stable for more than 14 weeks prior to the leukapheresis
• History of craniocerebral trauma, disturbance of consciousness, epilepsy, cerebrovascular ischemia, cerebrovascular hemorrhagic diseases, dementia, cerebellar disease, or any autoimmune disease with central nervous system (CNS) involvement
• Female subject of childbearing potential who: a. Has positive pregnancy test result; or b. Is lactating
• Female subjects of childbearing potential, or male subject with female spouse/partner of childbearing potential, who refuses to adopt at least one form of birth control from the date of signing informed consent to 12 months after GF-CART01 infusion. Acceptable forms of birth control include: a. Established use of oral, injected or implanted hormonal methods of contraception b. Placement of an intrauterine device (IUD) or intrauterine system (IUS) c. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps)

Sponsors & Collaborators

• GenomeFrontier Therapeutics TW Co., Ltd.: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Howard Cheng

CONTACT

+886-2-2655-8766; howardcheng@genomefrontier.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 25, 2024
• Study Start: June 9, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)