BAFF CAR-T Cells for Chronic Lymphocytic Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called BAFF CAR-T cells, a type of immunotherapy, for individuals with chronic lymphocytic leukemia (CLL) who haven't responded well to previous treatments. The goal is to determine if this approach, which modifies a person's immune cells to fight cancer, can be effective after other options like BTK inhibitors and BCL2 inhibitors have failed. The trial seeks participants with active and measurable CLL or small lymphocytic lymphoma (SLL) who have relapsed after at least two treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that you must wait more than 2 weeks since prior radiation therapy or 5 half-lives for systemic therapy before leukapheresis, and you cannot use corticosteroids within 2 days before the infusion, except for preventing nausea during chemotherapy.
Is there any evidence suggesting that BAFF CAR-T Cells (LMY-920) are likely to be safe for humans?
Research shows that BAFF CAR-T cells, such as LMY-920, are being tested for safety in treating chronic lymphocytic leukemia (CLL). In earlier studies, a small number of patients with various types of lymphoma received these CAR-T cells. The treatment was generally well-tolerated, with most patients handling it well. Some experienced side effects like fever and low blood pressure, which are common with CAR-T therapies. However, no severe or unexpected reactions occurred.
As this is an early-phase study, the primary goal is to assess the treatment's safety and tolerability. Researchers are determining the optimal dose and monitoring for any side effects. While early data suggests safety, further research is necessary to confirm this for CLL patients.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for Chronic Lymphocytic Leukemia (CLL), which often include chemotherapy and targeted therapies like BTK inhibitors, BAFF CAR-T cells (LMY-920) offer a novel approach by harnessing the body's immune system to fight cancer. This treatment is unique because it involves genetically modifying a patient's T-cells to specifically target and destroy cancer cells, potentially leading to more precise and effective results. Researchers are excited about BAFF CAR-T cells because they represent a personalized therapy that might offer longer-lasting remission with fewer side effects compared to traditional CLL treatments.
What evidence suggests that BAFF CAR-T Cells might be an effective treatment for chronic lymphocytic leukemia?
Research has shown that BAFF CAR-T cells, which participants in this trial will receive, could be a promising treatment for chronic lymphocytic leukemia (CLL). In lab studies, these cells found and destroyed CLL cancer cells, even those resistant to other treatments. BAFF CAR-T cells target the BAFF receptor, a specific part often present on CLL cells. Early results suggest these cells can significantly reduce the number of cancer cells, offering hope for a new treatment option for patients who don't respond to current therapies.12367
Who Is on the Research Team?
Paolo Caimi, MD
Principal Investigator
Case Comprehensive Cancer Center, Cleveland Clinic Taussig Cancer Institute
Are You a Good Fit for This Trial?
This trial is for people with Chronic Lymphocytic Leukemia (CLL) or Non-Hodgkin's Lymphoma that hasn't improved after standard treatments. Participants should have enough healthy blood cells and organ function to undergo the therapy. Specific eligibility details are not provided, but typically include age, overall health status, and disease characteristics.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Lymphodepletion
Participants undergo B cell depletion with Obinutuzumab prior to apheresis
Treatment
Participants receive BAFF CAR-T cells (LMY-920) for treatment of relapsed or refractory CLL/SLL
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BAFF CAR-T Cells (LMY-920)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Paolo Caimi, MD
Lead Sponsor
The Leukemia and Lymphoma Society
Collaborator