CAR-T Therapy for B-Cell Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase I trial evaluates the side effects and usefulness of axicabtagene clioleucel (a CAR-T therapy) and find out what effect, if any, it has on treating patients with HIV-associated aggressive B-cell non-Hodgkin lymphoma that has come back (relapsed) or not responded to treatment (refractory). T cells are infection fighting blood cells that can kill tumor cells. Axicabtagene ciloleucel consists of genetically modified T cells, modified to recognize CD-19, a protein on the surface of cancer cells. These CD-19-specific T cells may help the body's immune system identify and kill CD-19-positive B-cell non-Hodgkin lymphoma cells.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, certain treatments like corticosteroids, chemotherapy, and immunosuppressive therapies must be stopped within specific timeframes before certain procedures. It's best to discuss your current medications with the trial team to understand any necessary adjustments.
Is CAR-T therapy (Axicabtagene Ciloleucel) safe for humans?
CAR-T therapy, known as Axicabtagene Ciloleucel or Yescarta, has been studied for safety in treating B-cell lymphomas. Common side effects include cytokine release syndrome (a condition where the immune system is overly activated) and neurological issues, but these are generally manageable. Other side effects can include infections, fever, diarrhea, nausea, low blood pressure, and fatigue.12345
How is the treatment Axicabtagene Ciloleucel unique for B-cell lymphoma?
Axicabtagene Ciloleucel is a unique treatment for B-cell lymphoma because it is a CAR T-cell therapy that uses the patient's own modified immune cells to target and destroy cancer cells, specifically those expressing the CD19 antigen. This approach is different from traditional chemotherapy as it offers a personalized and targeted treatment option for patients with relapsed or refractory B-cell lymphoma who have not responded to other therapies.26789
What data supports the effectiveness of the treatment Axicabtagene Ciloleucel (Axi-cel) for B-cell lymphoma?
Axicabtagene Ciloleucel (Axi-cel) has shown high response rates in patients with relapsed or refractory large B-cell lymphoma, with studies reporting significant improvements in survival compared to standard care. It is approved by the FDA for use in certain types of B-cell lymphoma after other treatments have failed.246710
Who Is on the Research Team?
Ariela Noy
Principal Investigator
AIDS Malignancy Consortium
Are You a Good Fit for This Trial?
This trial is for adults over 18 with HIV and aggressive B-cell non-Hodgkin lymphoma that's relapsed or resistant to treatment. They must have had at least two prior therapies including an anthracycline and rituximab, be PET-positive or have bone marrow involvement, and be in fairly good health (ECOG <=1).Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Conditioning
Patients receive fludarabine and cyclophosphamide intravenously to prepare for CAR-T cell therapy
Treatment
Patients receive axicabtagene ciloleucel intravenously
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Axicabtagene Ciloleucel
Axicabtagene Ciloleucel is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
AIDS Malignancy Consortium
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Memorial Sloan Kettering Cancer Center
Collaborator
Kite, A Gilead Company
Industry Sponsor