Autologous T Cells

A Phase I Study of Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, and Other Hematologic Malignancies

What's the purpose of the 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.
Trial status

Not yet accepting

Phase
Phase 1
Enrollment
86
Last Updated
3 days ago

For Healthcare Professionals Only

This site is intended for healthcare professionals in the US. Patients and care partners can explore and connect with MDS clinical trials through our patient portal.

Participating Centers

There is one center participating in this trial. Enter a location below to view the distance.

Experimental Treatments

Learn more about the experimental treatments being evaluated in this clinical trial.

  • Cyclophosphamide is a chemotherapy agent used in the treatment of cancer.
  • Fludarabine is a chemotherapy medication that may be used in the treatment of many different cancers.
  • Interleukin-2 is an immunotherapy drug used to treat several different indications. It works to help certain parts of your immune system to increase production of immune cells.

Arms / Cohorts

Explore eligibility, treatments and learn more about potential cohorts.

Not yet accepting

MDS Patients: No allo-HSCT

Not yet accepting

MDS Patients: Prior allo-HSCT

Not yet accepting

Multiple Myeloma Patients: No allo-HSCT

Real People. Real Support.

Need help connecting with this clinical trial? We're here to help!

Print a patient-friendly report to share with your patient.

We can help answer any questions and connect you (or your patient) with the study team.

Schedule a time that is convenient and we’ll call you to see how we can help you and your patient.