Study on NX-5948 for Adults with CLL/SLL Previously Treated with BTK and BCL-2 Inhibitors
Sponsor: Nurix Therapeutics, Inc.
ClinicalTrials ID:NCT07221500
This clinical trial is testing a new drug, NX-5948, to see if it can effectively treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have already tried other treatments. The study will also check how safe the drug is and how it behaves in the body over time.
Patient Parameters
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Program Overview
This study is for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has come back or not responded to previous treatments. The main goal is to see if a new drug, NX-5948, can help treat these conditions. NX-5948 works by breaking down a protein called BTK, which is different from other drugs that only block part of the protein's action. Participants will take NX-5948 by mouth and continue as long as it helps and is safe. Regular health check-ups will be part of the study, which could last up to 5 years or more if the cancer does not progress.
Description
The study aims to find out how well NX-5948 works for patients with CLL/SLL who have already been treated with BTK and BCL-2 inhibitors. NX-5948 is a new type of drug that destroys the BTK protein, potentially stopping the cancer from growing. Researchers want to know:
- How effective is NX-5948 in treating patients who have tried other treatments?
- Is NX-5948 safe for long-term use?
- How does NX-5948 move through the body over time?
All participants will take NX-5948 until their cancer worsens or they need to stop for other reasons. Regular check-ups will monitor the cancer and overall health. If the cancer remains stable, participants will continue to have check-ups even if they stop taking the drug.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have confirmed relapsed or refractory CLL/SLL that requires treatment.
- Be in good general health with an ECOG performance status of 0 to 2.
- Have previously received both types of BTK inhibitors and a BCL-2 inhibitor.
- Have measurable cancer as shown by scans.
- Have good organ and bone marrow function.
- Must agree to participate and sign a consent form.
Exclusion Criteria
- Have a different type of leukemia or transformation known as Richter's transformation.
- Have taken another experimental drug or cancer treatment recently.
- Have had antibody therapy within 4 weeks before starting the study drug.
- Cannot take other cancer treatments during the study, except certain hormonal therapies.
- Have had recent radiotherapy, except for specific cases.
- Have used high-dose steroids recently, except for specific medical reasons.
- Have used other immunosuppressive drugs recently.
- Have been treated with a BTK degrader before.
- Have had CAR T-cell therapy or a stem cell transplant within the last year.
- Have had recent serious blood clots, strokes, or brain bleeding.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Colorado Blood Institute | 80218 | Denver | Colorado |
| Florida Cancer Specialists | 34232 | Sarasota | Florida |
| University of Iowa | 52242 | Iowa City | Iowa |
| Maryland Oncology Hematology | 20904 | Silver Spring | Maryland |
| Novant Health Cancer Institute | 27103 | Winston-Salem | North Carolina |
| University of Cincinnati | 45221 | Cincinnati | Ohio |
| Oncology Hematology Care | 45014 | Fairfield | Ohio |
| SCRI Oncology Partners | 37203 | Nashville | Tennessee |
| Texas Oncology - Center South | 78705 | Austin | Texas |
| Virginia Cancer Specialists, PC | 22031 | Fairfax | Virginia |
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