This study looks at NX-2127, a new medicine, for adults with certain types of B-cell cancers that have not responded to previous treatments. The goal is to understand how safe NX-2127 is and how well it works for these patients. The study has two phases: the first checks safety, and the second looks at how effective the treatment can be based on what was learned in the first phase.
The trial ID is NCT04830137. It is a Phase 1 study, which means it is the first time this treatment is being tested in people to see how well it works and how safe it is. The trial is FDA-regulated and aims to include about 248 participants.
Who can join
This trial is for adults aged 18 and older. It is open to both men and women. Participants must have specific B-cell cancers that have not responded to other treatments. There are some health conditions and circumstances that would prevent someone from joining, but the trial team will confirm eligibility for each person.
Conditions
Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), Waldenstrom Macroglobulinemia (WM), Mantle Cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL), Follicular Lymphoma (FL), Diffuse Large B-cell Lymphoma (DLBCL), Primary Central Nervous System Lymphoma (PCNSL)
Age group
Adult, Older adult
Sex
All sexes
The study team makes the final call on eligibility.
What happens in the study
Participants will take NX-2127, which is an oral medicine. The study has different groups, where some will receive varying doses of NX-2127 to see which works best. The first part focuses on safety, while the second part will assign participants to one of two doses at random to compare effects.
Where
This trial is running at 16 locations in the United States. 7 of them are currently recruiting.
City of Hope
Duarte, California
Recruiting
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah
Recruiting
MD Anderson Cancer Center
Houston, Texas
Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland
Recruiting
Sarah Cannon Research Institute at Colorado Blood Cancer Institute
Denver, Colorado
Recruiting
Tennessee Oncology
Nashville, Tennessee
Recruiting
The University of Chicago Medical Center
Chicago, Illinois
Recruiting
Baylor University Medical Center
Dallas, Texas
Completed
The first 8 of 16 sites are listed here. The registry record has the full list.