Memory-Enriched T Cells for Non-Hodgkin's Lymphoma
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are on other investigational drugs, certain doses of corticosteroids, or if you have an active autoimmune disease requiring systemic treatment.
What data supports the effectiveness of the treatment for Non-Hodgkin's Lymphoma?
Research shows that similar treatments using modified T cells, like CD19 CAR T cells, have been effective in treating B-cell malignancies, including Non-Hodgkin's Lymphoma. In one study, 75% of patients treated with a similar T cell therapy were progression-free at one year, indicating promising results for this type of treatment.12345
Is the Memory-Enriched T Cell treatment safe for humans?
The Memory-Enriched T Cell treatment has been tested in clinical trials for non-Hodgkin's lymphoma, showing it to be generally safe with manageable side effects. Common side effects include mild cytokine release syndrome (a reaction where the immune system releases too many proteins into the blood too quickly) and no severe neurotoxicity (damage to the nervous system).34678
How is the treatment for Non-Hodgkin's Lymphoma using memory-enriched T cells different from other treatments?
This treatment uses specially engineered T cells that are enriched for memory characteristics, which may help them persist longer and be more effective in fighting cancer. Unlike standard treatments, these T cells are designed to target specific cancer markers, potentially leading to better outcomes for patients with relapsed or refractory Non-Hodgkin's Lymphoma.456910
What is the purpose of this trial?
This phase I trial studies the highest possible dose of memory enriched T cells that can be given following standard stem cell transplant before unmanageable side effects are seen in patients with B-cell non-Hodgkin lymphoma that has returned after previous treatment. A T cell is a type of immune cell that can recognize and kill abnormal cells of the body. Memory enriched T cells will be made from a patient's own T cells that are genetically modified in a laboratory. This means that the T cells are changed by inserting additional pieces of deoxyribonucleic acid (genetic material) into the cell to make it recognize and kill lymphoma cells. Memory enriched T cells may kill the cells that are not killed by stem cell transplant and may lower the chances of the cancer recurring.
Research Team
Elizabeth Budde, MD, PhD
Principal Investigator
City of Hope Medical Center
Eligibility Criteria
This trial is for patients with recurrent B-cell non-Hodgkin lymphoma who are eligible for a stem cell transplant. They must have a life expectancy of at least 16 weeks, not require oxygen support, and have good organ function. Pregnant women or those on corticosteroids/immunosuppressives can't join. Participants need to agree to use contraception during the study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing T cells following HSCT
Follow-up
Participants are monitored for safety and effectiveness after treatment
Optional Second T Cell Infusion
Patients who experience disease progression and have not experienced serious treatment-related toxicities may receive an optional second T cell infusion
Treatment Details
Interventions
- Autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tcm-enriched T cells
- Autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator