T Cell Receptor Immunotherapy Targeting MAGE-A3 for Patients With Metastatic Cancer Who Are HLA-DP0401 Positive
Status:
Completed
Trial end date:
2021-03-24
Target enrollment:
Participant gender:
Summary
Background:
The NCI Surgery Branch has developed an experimental therapy for treating patients with
metastatic cancer that involves taking white blood cells from the patient, growing them in
the laboratory in large numbers, genetically modifying these specific cells with a type of
virus (retrovirus) to attack only the tumor cells, and then giving the cells back to the
patient. This type of therapy is called gene transfer. In this protocol, we are modifying the
patient s white blood cells with a retrovirus that has the gene for anti-MAGE-A3-DP0401/0402
incorporated in the retrovirus.
Objective:
The purpose of this study is to determine a safe number of these cells to infuse and to see
if these particular tumor-fighting cells (anti-MAGE-A3-DP0401/0402 cells) cause tumors to
shrink and to be certain the treatment is safe.
Eligibility:
- Adults age 18-70 with metastatic cancer expressing the MAGE-A3 molecule.
Design:
- Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and
undergo a history and physical examination, scans, x-rays, lab tests, and other tests as
needed
- Leukapheresis: If the patients meet all of the requirements for the study they will
undergo leukapheresis to obtain white blood cells to make the anti-MAGE-A3-DP0401/0402
cells. {Leukapheresis is a common procedure, which removes only the white blood cells
from the patient.}
- Treatment: Once their cells have grown, the patients will be admitted to the hospital
for the conditioning chemotherapy, the anti-MAGE-A3-DP0401/0402 cells and aldesleukin.
They will stay in the hospital for approximately 4 weeks for the treatment.
- Follow up: Patients will return to the clinic for a physical exam, review of side
effects, lab tests, and scans about every 1-3 months for the first year, and then every
6 months to 1 year as long as their tumors are shrinking.