Actively Recruiting
Phase 1a/1b Study of BAFFR-Based CAR T-Cells with Fludarabine and Cyclophosphamide for Relapsed or Refractory B-Cell Hematologic Malignancies
Led by Mayo Clinic · Updated on 2026-02-13
27
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, side effects, and best dose of a new treatment called BAFFR-based chimeric antigen receptor (CAR) T-cells combined with chemotherapy drugs fludarabine and cyclophosphamide for patients with B-cell blood cancers that have returned or are resistant to treatment. This phase I trial aims to find the recommended doses and assess the treatment's effectiveness and long-term effects in patients with these difficult-to-treat cancers. The study also explores how the treatment interacts with the cancer cells at the molecular level. Participants first undergo a process called leukapheresis to collect their T cells. They then receive chemotherapy with cyclophosphamide and fludarabine or bendamustine to prepare the body. On day 0, patients receive an infusion of their modified BAFFR-targeting CAR T-cells. Various imaging tests like echocardiography, MRI, CT, and PET scans, as well as bone marrow biopsies and blood samples, are taken before and during the study to monitor disease and treatment effects. After receiving treatment, patients are closely followed up on multiple days within the first month and then periodically for up to 15 years to monitor safety and treatment outcomes. Researchers measure dose-related toxicities, adverse events, response rates, survival, and long-term side effects. The study includes detailed assessments to understand treatment behavior and cancer response, ensuring ongoing safety and effectiveness evaluation over many years.
CONDITIONS
Brief 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 malignancy including CLL/SLL, follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, or large B-cell lymphoma
- Relapsed or refractory disease defined by specific biopsy and imaging criteria
- Received at least two prior lines of therapy or specific prior treatments as detailed for each disease type
- Measurable disease present
- Positive test for BAFFR expression
- ECOG performance status of 0, 1, or 2
- Adequate blood counts and organ function within 14 days prior to registration
- Negative pregnancy test for persons of childbearing potential
- Ejection fraction of 45% or higher
- Pulse oximetry over 92% on room air
- Willingness to provide blood samples and attend follow-up visits
You will not qualify if you...
- Prior solid organ transplantation
- Unstable angina, significant arrhythmia, recent myocardial infarction within 6 months, or severe pericardial effusion
- Prior anti-BAFFR therapies
- Contraindication to lymphodepleting chemotherapy
- Use of systemic antitumor or investigational therapy within 14 days prior
- Ongoing active infections or uncontrolled illnesses
- Pregnancy or breastfeeding
- Life expectancy less than 6 weeks
- Use of systemic corticosteroids above specified doses
- Active central nervous system malignancy or brain metastases
- History of seizure disorder, dementia, or autoimmune disease with CNS involvement
- Recent radiation therapy within 14 days
- Recent allogeneic stem cell transplant within 6 months or active graft versus host disease
- HIV positive or active hepatitis B or C infection
- Advanced heart failure (NYHA class III or higher)
- Active bacterial, viral, or fungal infections
- Previous or concurrent malignancy except certain skin or in situ cancers
- Any other condition that may limit study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 week
Participants undergo leukapheresis followed by lymphodepleting chemotherapy with cyclophosphamide and fludarabine or bendamustine. They then receive BAFFR-based CAR T-cell infusion.
Visits on day -5 to -3 or day -4 and -3 for chemotherapy, and day 0 for CAR T-cell infusion
Duration - Up to 15 years
Participants are closely monitored after treatment with multiple visits to assess safety, efficacy, and long-term outcomes.
Visits at day 1, 2, 3, 4, 8, 11, 14, 21, 28, 60, 90, 180, 270, 365, 545, 730 and then periodically
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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