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Tests treatment safety and results for Diffuse Large B Cell Lymphoma Relapsed
Official title 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
ClinicalTrials.gov ID: NCT06703892
What this study is testing
What is GF-CART01?
GF-CART01 is an investigational medicine, being studied as a potential treatment for diffuse large b cell lymphoma relapsed.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- people must be of age ≥ 18 years and ≤ 70 years
- people 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...
- 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...
You likely can't join 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...
See the full eligibility criteria
Who can join
- people must be of age ≥ 18 years and ≤ 70 years
- people 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...
- 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...
- people 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
What rules you out
- 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
- people 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...
- people with atrial or ventricular involvement by B-cell malignancies
- people with tumor mass requiring urgent treatment within 8 weeks prior to the leukapheresis, such as ileus, tumor lysis syndrome, or vascular compression
- people with severe disease or other uncontrolled diseases, such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia (urgent intervention indicated, life- threatening consequences, or...
- Unstable pulmonary embolism, deep venous embolism, or other major arterial/venous thromboembolism events that occurred within 6 weeks prior to the leukapheresis. If people receive anticoagulant therapy, the treatment...
- History of craniocerebral trauma, disturbance of consciousness, epilepsy, cerebrovascular ischemia, cerebrovascular hemorrhagic diseases, dementia, cerebellar disease, or any autoimmune disease with central nervous...
- Female subject of childbearing potential who: a. Has positive pregnancy test result; or b. Is lactating
- Female people 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...
- Any following situations that the investigators believe are not suitable for this trial and/or may increase the risk for people or interfere with the results of the study a. With severe active infections (except simple...
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.