Cancer Type: Hematology
An open label phase 1/2 Study of MEDI-551, a Humanized Monoclonal Antibody Directed Against CD19, in Adult Subjects with Relapsed or Refractory Advanced B-Cell Malignancies.
People who have leukemia, lymphoma, or multiple myeloma that has not responded to or stopped responding to treatment with standard anticancer medicines will be enrolled in this study.
Leukemias, lymphomas, and multiple myeloma are types of cancers. Some leukemias and lymphomas involve B cells. B cell is a type of white blood cell that makes antibodies, which are proteins that are also an important part of the body's immune system. . In most B-cell cancers, a protein called CD19 is expressed on the outside of the B cells.
MEDI-551 an antibody against CD19 is being studied to see if it might slow the cancer's growth or stop it from spreading to other parts of the body. For patients with B-cell cancers, such as leukemia and lymphoma, whose cancer has not slowed down or has returned after treatment with other anticancer medicines, experimental treatments such as MEDI-551 may be an option.
The purpose of this study is to test the safety of MEDI-551 when given at different doses and see what effects it has on people with certain B-cell cancers.
The study will also measure pharmacokinetics of the study drug and immune response to the study drug.
A Phase 2, Open-Label Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacodynamics of GS-9973 in Combination with Idelalisib in Subjects with Relapsed or Refractory Hematologic Malignancies.
This research study will evaluate the combination of two investigational drugs named GS-9973 and Idelalisib (formerly know as GS-1101) for the treatment of your cancer.
All cells in the body receive signals to grow and survive, but sometimes these signals get out of control, causing too much cell growth. When the growth of lymphocytes (a type of white blood cell) gets out of control, cancers like CLL, MCL, DLBCL, FL or other iNHLs can develop. Drugs like GS 9973 and Idelalisib block some of the cell functions that cause these cancers to grow and survive and may also help control the disease
The purpose of this study is to see if GS-9973 in combination with Idelalisib can benefit patients with CLL, MCL, DLBCL, FL and other iNHLs. This study will also investigate how safe and well tolerated these study drugs are.
Both study drugs tested in this study are investigational drugs, which mean it is still being tested in people and has not been approved by the FDA.