TCR-Transduced T Cells for Blood Cancers
Trial Summary
What is the purpose of this trial?
Background: Blood cancers (such as leukemias) can be hard to treat, especially if they have mutations in the TP53 or RAS genes. These mutations can cause the cancer cells to create substances called neoepitopes. Researchers want to test a method of treating blood cancers by altering a person s T cells (a type of immune cell) to target neoepitopes. Objective: To test the use of neoepitope-specific T cells in people with blood cancers Eligibility: People aged 18 to 75 years with any of 9 blood cancers. Design: Participants will have a bone marrow biopsy: A sample of soft tissue will be removed from inside a pelvic bone. This is needed to confirm their diagnosis and the TP53 and RAS mutations in their cancer cells. They will also have a skin biopsy to look for these mutations in other tissue. Participants will undergo apheresis: Blood will be taken from their body through a vein. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different vein. The T cells will be grown to become neoepitope-specific T cells. Participants receive drugs for 3 days to prepare their body for the treatment. The modified T cells will be given through a tube inserted into a vein. Participants will need to remain in the clinic at least 7 days after treatment. Participants will have 8 follow-up visits in the first year after treatment. They will have 6 more visits over the next 4 years. Long-term follow-up will go on for 10 more years.
Research Team
James N Kochenderfer, M.D.
Principal Investigator
National Cancer Institute (NCI)
Eligibility Criteria
This trial is for adults aged 18 to 75 with one of nine specific blood cancers, including various leukemias and myelodysplastic syndromes. Participants must have a confirmed diagnosis with TP53 or RAS mutations. They should be able to undergo procedures like bone marrow biopsy and apheresis.Inclusion Criteria
Treatment Details
Interventions
- Individual Patient TCR-Transduced PBL
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor