Actively Recruiting
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
Led by Mayo Clinic · Updated on 2026-02-13
27
Participants Needed
1
Research Sites
876 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving chemotherapy, such as fludarabine and cyclophosphamide, helps ill cancer cells in the body and helps prepare the body to receive the BAFFR based chimeric antigen receptor T-cells. Giving BAFFR based chimeric antigen receptor T-cells with fludarabine and cyclophosphamide for lymphodepletion may work better for the treatment of patients with relapsed or refractory B-cell hematologic malignancies.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed diagnosis of relapsed or refractory B-cell hematologic malignancies including chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, or large B-cell lymphoma including Richter's transformation
- For CLL/SLL, received at least two prior therapies and/or six months of BTK inhibitor with failure or intolerance to venetoclax
- For follicular, mantle cell, marginal zone, and large B-cell lymphoma, received at least two prior therapies including an anti-CD20 antibody
- Prior CD19-directed CAR T-cell therapy must have a 100-day washout period
- Measurable disease
- Positive BAFFR test
- ECOG performance status 0, 1, or 2
- Hemoglobin 9.0 g/dL or higher unless due to marrow disease
- Absolute neutrophil count 1500/mm3 or higher unless due to marrow disease
- Platelet count 100,000/mm3 or higher unless due to marrow disease
- Total bilirubin no more than 1.5 times upper normal limit (or higher for Gilbert's syndrome per criteria)
- ALT and AST no more than 3 times upper normal limit (or 5 times if liver involved)
- Coagulation tests (PT/INR/aPTT) no more than 1.5 times upper normal limit or within therapeutic range if on anticoagulants
- Creatinine clearance 45 ml/min or higher
- Negative pregnancy test if applicable
- Ability to provide informed consent
- Cardiac ejection fraction 45% or higher
- Pulse oxygen above 92% on room air
- Willingness to provide blood samples and return for follow-up
You will not qualify if you...
- Prior solid organ transplant
- Unstable angina, serious arrhythmia, recent heart attack within 6 months, or severe pericardial effusion
- Prior anti-BAFFR therapies
- Contraindication to lymphodepleting chemotherapy
- Antitumor therapy or investigational agent use within 14 days before pre-registration
- Receiving other investigational agents targeting BAFFR
- Autologous hematopoietic cell transplant within 60 days
- Uncontrolled illnesses including active infections, psychiatric illness, continuous oxygen need, or short life expectancy less than 6 weeks
- Use of systemic corticosteroids above 10 mg prednisone daily or other immunosuppressive therapy
- Malignant cells in cerebrospinal fluid or active brain metastases
- History of seizure disorder, major stroke, dementia, cerebellar disease, or autoimmune CNS disease
- Radiation therapy within 14 days
- Allogeneic hematopoietic stem cell transplant within 6 months or active graft versus host disease
- HIV infection
- New York Heart Association class III or higher heart failure
- Active bacterial, viral, or fungal infections uncontrolled
- Active hepatitis B or C infections
- Pregnancy or breastfeeding
- Other malignancies except certain skin or cervical cancers or those in remission over 5 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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