Purpose of this Study
We are doing this study to find the most effective, safe dose of an experimental drug called NX-5948 (the study drug). We want to know how well this study drug works in people with B-cell lymphomas.
Who Can Participate?
Eligibility
Adults ages 18+ who have one of the following diagnoses:<ul>
<li>Relapsed or refractory chronic lymphocytic leukemia (CLL)</li>
<li>Small lymphocytic leukemia (SLL)</li>
<li>Non-GCB diffuse large B-cell lymphoma (DLBCL)</li>
<li>Follicular lymphoma (FL)</li>
<li>Mantle cell lymphoma (MCL)</li>
<li>Marginal zone lymphoma (MZL)</li>
<li>Waldenstrom macroglobulinemia (WM)</li></ul>
Study candidates must also:<ul>
<li>Have received at least 2 prior lines of therapy</li>
<li>Not have active/ongoing graft versus host disease</li>
<li>Have adequate organ function</li></ul>
For more information about who can join this study, please contact the study team at 919-681-6580.
<li>Relapsed or refractory chronic lymphocytic leukemia (CLL)</li>
<li>Small lymphocytic leukemia (SLL)</li>
<li>Non-GCB diffuse large B-cell lymphoma (DLBCL)</li>
<li>Follicular lymphoma (FL)</li>
<li>Mantle cell lymphoma (MCL)</li>
<li>Marginal zone lymphoma (MZL)</li>
<li>Waldenstrom macroglobulinemia (WM)</li></ul>
Study candidates must also:<ul>
<li>Have received at least 2 prior lines of therapy</li>
<li>Not have active/ongoing graft versus host disease</li>
<li>Have adequate organ function</li></ul>
For more information about who can join this study, please contact the study team at 919-681-6580.
What is Involved?
If you choose to join this study, you will go through a screening period to find out if you are eligible. During this screening period, you will:<ul>
<li>Have a physical exam</li>
<li>Have a heart scan (ECG)</li>
<li>Have blood draws</li></ul>
If you are found to be eligible, you will take the study drug by mouth on day 1 of each 28-day cycle. You will continue to take the study drug for as long as the study doctor believes that you are benefitting from it. The study is expected to last for about three years.
After you stop taking the study drug, you will come in for 3 follow-up visits. We will keep in touch with you after the study ends to see how you are doing.
<li>Have a physical exam</li>
<li>Have a heart scan (ECG)</li>
<li>Have blood draws</li></ul>
If you are found to be eligible, you will take the study drug by mouth on day 1 of each 28-day cycle. You will continue to take the study drug for as long as the study doctor believes that you are benefitting from it. The study is expected to last for about three years.
After you stop taking the study drug, you will come in for 3 follow-up visits. We will keep in touch with you after the study ends to see how you are doing.
Study Details
Full Title
A Phase 1, Dose Escalation, and Cohort Expansion Study Evaluating NX-5948, a Bruton?s Tyrosine Kinase (BTK) Degrader, in Adults with Relapsed/Refractory B-cell Malignancies
Principal Investigator
Danielle
Brander
Protocol Number
PRO00113264
NCT ID
NCT05131022
Phase
I
Enrollment Status
Open to Enrollment