CAR-T Cells for Non-Hodgkin's Lymphoma
Trial Summary
What is the purpose of this trial?
This study will assess safety and feasibility of infusing genetically modified autologous T cells transduced to express a chimeric antigen receptor targeting the B cell surface antigen Cluster of Differentiation 19 (CD19)
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot use corticosteroids within 7 days before the infusion, except for preventing nausea during chemotherapy.
What data supports the effectiveness of the treatment for Non-Hodgkin's Lymphoma?
Is CAR-T cell therapy safe for humans?
CAR-T cell therapy, including anti-CD19 CAR-T cells, has been shown to be effective but can have side effects like cytokine release syndrome (a severe immune reaction) and neurotoxicity (nerve damage). These side effects are generally manageable with proper medical care, but ongoing research is needed to better understand and reduce these risks.678910
How does the treatment with anti-CD19 CAR-T cells differ from other treatments for non-Hodgkin's lymphoma?
Anti-CD19 CAR-T cell therapy is unique because it uses the patient's own immune cells, which are modified to specifically target and destroy cancer cells in non-Hodgkin's lymphoma. This approach is different from traditional treatments like chemotherapy, as it harnesses the body's immune system to fight the cancer.411121314
Research Team
C. Babis Andreadis, MD
Principal Investigator
University of California, San Francisco
Eligibility Criteria
Adults with certain types of B-cell Non-Hodgkin Lymphoma that have relapsed or didn't respond to previous treatments can join. They should not be eligible for stem cell transplant, must have tried at least two systemic therapies, and still show CD19 positive cells. Key organ functions need to be within normal ranges, they shouldn't have other active cancers or severe illnesses, and women who can get pregnant must agree to use contraception for a year after treatment.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Apheresis and CAR-T Cell Manufacturing
Participants undergo apheresis for collection of autologous peripheral blood mononuclear cells, followed by CAR-T cell manufacturing
Lymphodepleting Chemotherapy
Participants receive 3 days of immunosuppressive chemotherapy with cyclophosphamide and fludarabine
CAR-T Cell Infusion
Participants receive a single infusion of anti-CD19 CAR-T cells
Follow-up
Participants are monitored for safety, disease status, and survival
Long-term Follow-up
Participants are followed for long-term safety and survival
Treatment Details
Interventions
- anti-CD19 CAR-T cells
- Cyclophosphamide
- Fludarabine
Find a Clinic Near You
Who Is Running the Clinical Trial?
C. Babis Andreadis
Lead Sponsor
University of California, Davis
Collaborator