This phase 2 trial is evaluating how well CD8+ memory T-cell therapy works in patients with leukemia or lymphoma after a stem cell transplant (SCT). The main outcome to be measured will be the number of patients who have full chimerism (donor cells work completely and only donor cells can be identified after transplant) after therapy. This trial is recruiting in Stanford, California.
Allogeneic SCT involves collecting healthy stem cells from a donor. Then, these cells are introduced into the patient. These donated cells help the patient’s bone marrow make new blood cells. Once the donated cells start working, the body’s immune system starts attacking remaining cancer cells. Giving the patient white blood cells from the same donor can help boost the body’s immune system. This is called CD8+ memory T-cell therapy.
This study is evaluating how well CD8+ memory T-cell therapy works in patients with leukemia or lymphoma after SCT. The main outcome to be measured will be the number of patients whose stem cells are fully from the donor (full chimerism) after therapy.
Who are they looking for?
This study is recruiting 40 patients with leukemia or lymphoma. Patients must have an adult sibling to serve as a donor. At the time of cell therapy, patients must not have graft-versus-host disease (GVHD). This condition develops when the donated cells attack the patient’s healthy cells. It is a common complication of SCT. Patients should also have adequate liver and kidney function, they should be on a immune suppression medication and should not have any active infections.
Donors should not have HIV, hepatitis B, or hepatitis C or any cancer. Female donors must not be pregnant or breastfeeding.
Patients who are HIV-positive or have uncontrolled infections cannot participate. Patients with a history of prior cancer cannot participate. Patients with cancer in the brain or spinal cord, those with psychiatric, heart, liver or lung conditions cannot participate. Patients who are pregnant or breastfeeding cannot participate.
How will it work
All patients will first receive radiation therapy, followed by allogeneic SCT. At 1 to 3 months after the transplant, patients will receive CD8+ memory T-cells from the same donor.
The main outcome to be measured will be the number of patients who have full chimerism after therapy. The number of patients who develop GVHD or experience other side effects will also be measured. Patients will be followed-up for up to 1 year after treatment.