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New treatment option for B-Cell Non-Hodgkin Lymphoma
Official title B-Cell Activating Factor Receptor (BAFFR)-Based Chimeric Antigen Receptor T-Cells With Fludarabine and Cyclophosphamide Lymphodepletion for the Treatment of Relapsed or Refractory B-cell Hematologic Malignancies
ClinicalTrials.gov ID: NCT06191887
What this study is testing
What is Autologous BAFFR-targeting CAR T Cells?
Autologous BAFFR-targeting CAR T Cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for b-cell non-hodgkin lymphoma.
Also referred to as Autologous BAFFR-CAR T Cells, Autologous BAFFR-CAR-expressing T-cells.
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 phase I trial tests safety, side effects and best dose of B-cell activating factor receptor (BAFFR)-based chimeric antigen receptor T-cells, with fludarabine and cyclophosphamide lymphodepletion, for the treatment of patients with B-cell hematologic malignancies that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). BAFFR-based chimeric antigen receptor T-cells is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells.
- 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 and older
You may be able to join if
- PRE-REGISTRATION: Age ≥ 18 years
- PRE-REGISTRATION: Confirmed diagnosis of 1 of the following relapsed or refractory B-cell hematologic malignancies: chronic lymphocytic...
- For CD19+ B cell malignancies; relapsed or refractory disease is defined by one of the following histopathology:
- Biopsy proven SLL or flow cytometry proven CLL; relapsed or refractory disease is defined as:
- Demonstration of progressive or stable disease by positron emission tomography/computed tomography (PET/CT) or computed tomography (CT) criteria...
You likely can't join if
- PRE-REGISTRATION: Prior solid organ transplantation
- PRE-REGISTRATION: Unstable angina, clinically significant arrhythmia, or myocardial infarction ≤ 6 months of prior to pre-registration, or grade 3 or...
- PRE-REGISTRATION: Prior anti-BAFF-R therapies
- PRE-REGISTRATION: Known contraindication to lymphodepleting (LD) chemotherapy
- PRE-REGISTRATION: Use of systemic antitumor therapy or investigational agent ≤ 14 days, prior to pre-registration
- PRE-REGISTRATION: Receiving any other investigational agent which would be considered as a treatment for the BAFF-R
See the full eligibility criteria
Who can join
- PRE-REGISTRATION: Age ≥ 18 years
- PRE-REGISTRATION: Confirmed diagnosis of 1 of the following relapsed or refractory B-cell hematologic malignancies: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), follicular lymphoma (FL), mantle...
- For CD19+ B cell malignancies; relapsed or refractory disease is defined by one of the following histopathology:
- Biopsy proven SLL or flow cytometry proven CLL; relapsed or refractory disease is defined as:
- Demonstration of progressive or stable disease by positron emission tomography/computed tomography (PET/CT) or computed tomography (CT) criteria according to the international workshop on chronic lymphocytic leukemia...
- Biopsy proven B-cell non-Hodgkin lymphoma (NHL) of any histopathology (including Richter Transformation of CLL); relapsed or refractory disease is defined as:
- Demonstration of progressive or stable disease by PET/CT or CT criteria as the best response to the most recent chemotherapy regimen according to the revised Lugano Response Criteria for Malignant Lymphoma
- PRE-REGISTRATION: Disease Specific prior lines of therapies below:
- For CLL/SLL, patients must have received ≥ two prior lines of therapy, and/or ≥ 6 months of second line prior BTK inhibition (e.g. ibrutinib or other such as acalabrutinib or zanubrutinib) and must have failed to...
- These patients may or may not have received prior antibody directed against cluster of differentiation 20 (CD20).
- For Follicular Lymphoma, patients must have received ≥ two prior lines of therapy, including an antibody directed against CD20.
- NOTE: Prior cluster of differentiation 19 (CD19) directed chimeric antigen receptor T-cell therapy (CART) must have a 100-day washout period.
- For Mantle Cell Lymphoma, patients must have received ≥ two prior lines of therapy, including an antibody directed against CD20, and a BTK inhibitor.
- NOTE: Prior CD19 directed CART must have a 100-day washout period.
- For Marginal Zone Lymphoma, patients must have received ≥ two prior lines of therapy, including an antibody directed against CD20.
- NOTE: Prior CD19 directed CART must have a 100-day washout period.
- For Large B cell Lymphoma, patients must have received ≥ two prior lines of therapy, including an antibody directed against CD20. Prior exposure to CD19 directed CART will be allowed at the discretion of the Principal...
- NOTE: Prior failed CD19 directed CART must have a 100-day washout period
- For Richter's Transformation, patients must have received ≥two prior lines of therapy, including an antibody directed against CD20.
- 100-day washout period starts from the date of the last prior CAR-T infusion.
- PRE-REGISTRATION: Measurable disease
- REGISTRATION: Positive BAFFR test
- REGISTRATION: Measurable disease
- REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- REGISTRATION: Hemoglobin ≥ 9.0 g/dL (unless due to documented marrow involvement with disease) obtained ≤14 days prior to registration
- REGISTRATION: Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (unless due to documented marrow involvement with disease) obtained ≤14 days prior to registration
- REGISTRATION: Platelet count ≥100,000/mm\^3 (unless due to documented marrow involvement with disease) obtained ≤ 14 days prior to registration
- REGISTRATION: Total bilirubin ≤ 1.5 x upper limits of normal (ULN) (people with Gilbert's Syndrome may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN) obtained ≤ 14 days prior to...
- REGISTRATION: Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) obtained ≤ 14 days prior to registration
- REGISTRATION: Prothrombin time (PT)/international normalized ratio (INR) /activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range...
- Patients on a stable, maintenance regimen of anticoagulant therapy for ≥ 30 days prior to registration may have PT/INR measurements \> 1.5 X ULN if, in the judgment of the investigator, the patient is suitable for the...
- REGISTRATION: Calculated creatinine clearance ≥45 ml/min using the Cockcroft-Gault formula obtained ≤ 14 days prior to registration
- REGISTRATION: Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be...
- REGISTRATION: Provide written informed consent understand and comply with protocol-required study procedures
- REGISTARTION: Patients must have an ejection fraction (EF) of ≥ 45%
- REGISTRATION: Patients must have pulse ox measurements of \> 92% on room air
- REGISTRATION: Willingness to provide mandatory blood specimens for correlative research
- REGISTRATION: Willing to return to enrolling institution for study follow-up
What rules you out
- PRE-REGISTRATION: Prior solid organ transplantation
- PRE-REGISTRATION: Unstable angina, clinically significant arrhythmia, or myocardial infarction ≤ 6 months of prior to pre-registration, or grade 3 or higher pericardial effusion at the time of pre-registration
- PRE-REGISTRATION: Prior anti-BAFF-R therapies
- PRE-REGISTRATION: Known contraindication to lymphodepleting (LD) chemotherapy
- PRE-REGISTRATION: Use of systemic antitumor therapy or investigational agent ≤ 14 days, prior to pre-registration
- PRE-REGISTRATION: Receiving any other investigational agent which would be considered as a treatment for the BAFF-R
- PRE-REGISTRATION: Autologous HCT ≤ 60 days prior to pre-registration
- PRE-REGISTRATION: Uncontrolled intercurrent non-cardiac illness including, but not limited to:
- Previous or concurrent malignancy
- Ongoing or active infection
- Psychiatric illness/social situations
- Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy \ Persons of childbearing potential who are pregnant or breastfeeding
- Life Expectancy of \< 6 weeks
- Persons requiring systemic corticosteroids (\>10 mg prednisone or equivalent per day) and/or other immunosuppressive therapy. Patients are allowed to use topical corticosteroids
- Any other conditions that would limit compliance with study requirements
- PRE-REGISTRATION: Detectable malignant cells from cerebrospinal fluid (CSF) or magnetic resonance imaging (MRI) indicating brain metastases during screening, or a history of central nervous system (CNS) involvement by...
- PRE-REGISTRATION: History of a seizure disorder, major cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
- PRE-REGISTRATION: Radiation therapy ≤ 14 days prior to pre-registration
- PRE-REGISTRATION: Prior allogeneic hematopoietic stem cell transplant (HCT) in ≤ 6 months prior to pre-registration; patients with active graft versus host disease (GVHD) will not be eligible regardless of duration from...
- PRE-REGISTRATION: Human immunodeficiency virus (HIV) positive patients
- PRE-REGISTRATION: people with New York Health Association (NYHA) class III or greater heart failure
- REGISTRATION: Eligible for auto-HCT based on investigator judgement
- REGISTRATION: Presence of active bacterial, viral, or fungal infection that is uncontrolled, based on investigator judgment
- REGISTRATION: Patients with active hepatitis B or hepatitis C infections are excluded from the study. Patients who are documented to be HIV positive or proven HIV infection from testing are ineligible for the study...
- REGISTRATION: Previous or concurrent malignancy, except basal cell or squamous cell skin carcinoma, adequately resected and in situ carcinoma of cervix, or a previous malignancy that was completely resected and has been...
- REGISTRATION: Persons of childbearing potential who are pregnant or breastfeeding
- REGISTRATION: Life expectancy of \< 6 weeks
The study team makes the final eligibility decision.
Where it's taking place
- Jacksonville, Florida, United States
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jacksonville, Florida, United States. 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.