This trial is evaluating the safety and effectiveness of allogeneic CAR-T cell therapy (ALLO-715) in patients with multiple myeloma (MM) that has come back or stopped responding to treatment. The main outcome to be measured will be the number of patients who have side effects. This trial is recruiting in Denver, CO.
The details
Chimeric antigen receptor (CAR) T-cell therapy helps the immune system fight cancer cells. Immune cells called T-cells are removed from the blood. Then, the T-cells are genetically modified in a laboratory to produce a protein called CAR. These modified T-cells are called CAR-T cells. The CAR-T cells are reintroduced into the patient to attack the cancer cells.
There are two types of CAR-T cell therapy. Autologous CAR-T cell therapy uses T-cells from the patient’s blood. Allogeneic CAR-T cell therapy uses T-cells from a healthy donor. ALLO-715 is a type of allogeneic CAR-T cell therapy.
This study is evaluating the safety and effectiveness of ALLO-715 in patients with MM that has come back or stopped responding to treatment. The main outcome to be measured will be the number of patients who have side effects from treatment.
Who are they looking for?
This study is looking for 90 patients with MM that has come back or stopped responding to treatment. Patients should have received at least 3 prior lines of therapy, with no response to the last treatment line. Patients must have adequate kidney, liver, lung, heart, and bone marrow function.
Patients who currently have or had a history of thyroid or brain disorders, HIV or hepatitis infection cannot participate. Patients who received an autologous stem cell transplant within 6 weeks of study enrollment cannot participate. Patients who received an allogeneic stem cell transplant, gene therapy, or cell therapy cannot participate.
How will it work
All patients will receive chemotherapy and ALLO-647 first, followed by ALLO-715. ALLO-647 is a monoclonal antibody. This treatment binds to cancer cells and helps the body’s immune system attack the cancer.
The main outcome to be measured will be the number of patients who have side effects within 1 month of treatment. The number of patients who respond to ALLO-715 and survive for up to 2 years without tumor growth or spread will also be measured. The number of patients who have side effects from ALLO-647 will also be measured.
