CAR T-cell Therapy for Lymphoma and Leukemia
Trial Summary
What is the purpose of this trial?
This trial tests the safety and best dose of a new treatment using modified immune cells (CAR T-cells) for patients with certain recurring or hard-to-treat lymphoid cancers. The treatment involves giving patients a brief period of chemotherapy followed by an infusion of these specially designed cells to target and kill cancer cells. Anti-CD19 CAR T-cells currently represent transformational therapy for relapsed/refractory aggressive B-cell lymphomas where durable remissions can be induced in patients with previously incurable chemotherapy-refractory disease.
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, patients must be off immunosuppressive agents if they have had an allogeneic stem cell transplant or donor lymphocyte infusion within 2 months of the planned CAR-T cell infusion.
What data supports the effectiveness of the treatment Anti-CD19/CD20/CD22 CAR-T cells for lymphoma and leukemia?
Research shows that trispecific CAR-T cells targeting CD19, CD20, and CD22 can effectively eliminate tumors in preclinical models, even when some cancer cells lose one or more of these targets. This approach may prevent relapse by overcoming the issue of antigen loss, which is a common cause of treatment failure in traditional CAR-T therapies.12345
Is CAR T-cell therapy safe for humans?
CAR T-cell therapy, including those targeting CD19, CD20, and CD22, has shown a generally favorable safety profile in clinical trials for leukemia and lymphoma. Severe side effects like cytokine release syndrome (CRS) and neurotoxicity are rare, with most patients experiencing mild to moderate symptoms. Long-term safety data is still being gathered, but current studies suggest it is a promising and generally safe treatment option.16789
What makes the Anti-CD19/CD20/CD22 CAR-T cell treatment unique for lymphoma and leukemia?
This treatment is unique because it targets three different proteins (CD19, CD20, and CD22) on cancer cells, which helps prevent the cancer from escaping treatment by losing one of these targets. This multi-target approach is designed to reduce the risk of relapse and improve the effectiveness of the therapy compared to treatments that target only one or two proteins.123710
Research Team
Sumithira Vasu, MD
Principal Investigator
Ohio State University Comprehensive Cancer Center
Eligibility Criteria
Adults with certain relapsed or refractory lymphoid cancers, including non-Hodgkin lymphoma and various types of leukemia. Participants must have tried at least two prior therapies, have a minimum level of white blood cells, good heart and lung function, and agree to use highly effective contraception. Excluded are those with recent transplants, active infections or other malignancies that could affect the trial's safety.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Lymphodepletion
Patients receive cyclophosphamide and fludarabine to prepare the body before CAR T-cell therapy
CAR T-Cell Therapy
Patients receive anti-CD19/CD20/CD22 CAR-T cells intravenously
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Anti-CD19/CD20/CD22 CAR T-Cells
- Cyclophosphamide
- Fludarabine Phosphate
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sumithira Vasu
Lead Sponsor
National Cancer Institute (NCI)
Collaborator