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

Launched by GENOMEFRONTIER THERAPEUTICS TW CO., LTD. · Nov 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called GF-CART01 for patients with certain types of B-cell blood cancers that have not responded to previous treatments. The trial aims to find out how safe this treatment is and how well it works. It is open to adults aged 18 to 70 who have been diagnosed with conditions like diffuse large B-cell lymphoma or follicular lymphoma and have already tried at least two other treatments without success. Participants will be closely monitored to see how their bodies react to the treatment and to determine the best dose to use in future studies.

If you or a loved one is considering participating, it’s important to know that you will need to meet specific health criteria, such as having a certain level of blood cell counts and not having other serious medical conditions. During the trial, you will receive the GF-CART01 treatment and have regular check-ups to assess your health and response to the therapy. This study is currently recruiting participants, and joining could provide access to a promising new treatment option that is not yet available to the general public.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects must be of age ≥ 18 years and ≤ 70 years
• • 2. Subjects or their legal guardians must volunteer to participate in the study and sign the informed consent
• • 3. 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)
• • 4. Tumor cell surface expression of CD19 (+) and/or CD20 (+) by flow cytometry or immunohistochemistry staining
• • 5. 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
• • 6. Subjects have any accessible PET-positive lesion or measurable CT-positive lesion per Lugano 2014 criteria
• • 7. 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
• • 8. 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
• • 9. Adequate renal function: blood estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m2 (calculated by Modification of Diet in Renal Disease (MDRD) equation)
• • 10. Adequate cardiac function: echocardiogram or multigated blood pool analysis (MUGA) shows left ventricular ejection fraction (LVEF) ≥ 50%; and no clinically significant electrocardiogram (ECG) findings
• • 11. Adequate pulmonary function: no active infection in the lungs, blood oxygen saturation in indoor air ≥ 92%
• • 12. No clinically significant pleural effusion determined by the investigators
• • 13. Estimated survival time ≥ 3 months
• • 14. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
• • 15. Willingness and ability to comply with protocol-stated requirements, instructions, and restrictions in the investigator's judgement
• Exclusion Criteria:
• • 1. Previously treated with any CAR T cell product or allogenic hematopoietic stem cell transplant (HSCT)
• • 2. Known or suspected allergy, hypersensitivity, or intolerance to any ingredients of the investigational product (IP)
• • 3. Known medical history or possible risk for taking contrast agent(s) for positron emission tomography (PET) and/or computed tomography (CT) scan
• • 4. Received any other investigational product, cell therapy, or gene therapy within 12 weeks prior to the leukapheresis
• • 5. Received any tyrosine kinase inhibitor within 2 weeks prior to the leukapheresis
• • 6. 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
• • 7. Received any live vaccine from 2 weeks prior to the leukapheresis
• • 8. 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
• • 9. Subjects with atrial or ventricular involvement by B-cell malignancies
• • 10. Subjects with tumor mass requiring urgent treatment within 8 weeks prior to the leukapheresis, such as ileus, tumor lysis syndrome, or vascular compression
• • 11. 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)
• • 12. 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
• • 13. 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
• • 14. Female subject of childbearing potential who: a. Has positive pregnancy test result; or b. Is lactating
• • 15. 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)
• • 16. Any following situations that the investigators believe are not suitable for this trial and/or may increase the risk for subjects or interfere with the results of the study a. With severe active infections (except simple urinary tract infection and bacterial pharyngitis) b. With active central nervous system involvement by lymphoma, malignant cells in cerebrospinal fluid c. History of brain metastasis d. With uncontrolled malignancies e. Any toxicities due to prior therapy f. With any uncontrolled illness or a history of any illness