Genetically Modified 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 receiving other investigational agents, or concurrent biological, chemotherapy, or radiation therapy.
What data supports the effectiveness of the treatment Autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tcm-enriched T cells for Non-Hodgkin's Lymphoma?
In a study, patients with B-cell non-Hodgkin lymphoma who received genetically modified T cells after stem cell transplantation showed promising results, with 75% of patients remaining progression-free at 1 year. This suggests that the treatment may help control the disease and prevent relapse.12345
Is the genetically modified T-cell treatment for Non-Hodgkin's Lymphoma safe?
Studies show that genetically modified T-cell treatments, like CD19 CAR T-cell therapy, are generally safe in humans, with some patients experiencing mild side effects such as cytokine release syndrome (a reaction that can cause fever and low blood pressure) and neurotoxicity (nerve-related side effects). However, there is a potential risk of secondary cancers, and long-term follow-up is recommended to monitor for late toxicities.14678
How is the treatment with genetically modified T-cells for Non-Hodgkin's Lymphoma different from other treatments?
This treatment is unique because it uses genetically modified T-cells that are engineered to specifically target cancer cells, offering a personalized approach that works differently from traditional chemotherapy or radiation. It combines cell and gene therapy to enhance the immune system's ability to fight cancer, which is a novel approach compared to standard treatments.1391011
What is the purpose of this trial?
This phase I trial studies the side effects and best dose of genetically modified T-cells following peripheral blood stem cell transplant in treating patients with recurrent or high-risk non-Hodgkin lymphoma. Giving chemotherapy before a stem cell transplant helps stop the growth of cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Removing the T cells from the donor cells before transplant may stop this from happening. Giving an infusion of the donor's T cells (donor lymphocyte infusion) later may help the patient's immune system see any remaining cancer cells as not belonging in the patient's body and destroy them (called graft-versus-tumor effect)
Research Team
Elizabeth Budde
Principal Investigator
City of Hope Medical Center
Eligibility Criteria
This trial is for patients with recurrent or high-risk non-Hodgkin lymphoma who are scheduled for a stem cell transplant and have certain levels of healthy stem cells available. They must be able to understand the study, agree to use contraception, and not have uncontrolled infections or other cancers. People can't join if they've had allergic reactions to similar drugs, active hepatitis B/C or HIV, brain metastases, previous transplants, steroid dependence, or active autoimmune diseases.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Mobilization and Conditioning
Patients undergo mobilization for autologous stem cell collection with cytoreductive chemotherapy and filgrastim and/or plerixafor, followed by a myeloablative conditioning regimen
Stem Cell Transplantation
Hematopoietic stem cell transplantation is performed on day 0
T-cell Infusion
Patients receive CD19-CAR-specific/truncated EGFR lentiviral vector-transduced autologous T cells IV on day 2 or 3, which may be delayed up to day 45 if the patient is not yet eligible
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tcm-enriched T cells
- Autologous Hematopoietic Stem Cell Transplantation
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator