This is a study for patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received treatment with a BTK inhibitor (covalent and non-covalent) and a BCL-2 inhibitor. The main purpose of this study is to test if NX-5948 (bexobrutideg) works to treat patients with CLL/SLL. Participation could last up to 5 years, and possibly longer, if the disease does not progress.
Age: ≥ 18 years
Confirmed relapsed/refractory CLL/SLL that meets iwCLL criteria for diagnosis and systemic treatment
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Must have received a covalent BTK inhibitor (BTKi), a non-covalent BTKi, and a BCL-2 inhibitor either in separate lines of therapy or in combination; a line of therapy is considered 2 or more consecutive cycles of a systemic anti-CLL/SLL regimen
Known or suspected prolymphocytic leukemia or Richter's transformation before entering study
Investigational agent or anticancer therapy within 5 half-lives or 14 days (whichever is shorter) before planned start of study drug
Antibody therapy must stop at least 4 weeks before the first dose of study drug
No other systemic anticancer therapy is allowed at the same time as this study; exception: continuation of hormonal therapy for breast and prostate cancer is allowed, if they are not on the list of prohibited concomitant medications in this study
Single group
NX-5948
DrugOral dose administered once daily. NX-5948 will be given in continuous 28-day cycles.
Objective response rate without partial response with lymphocytosis (PR-L) as determined by an Independent Review Committee (IRC)
The percentage of participants with response as determined according to 2018 International Workshop on CLL (iwCLL) guidelines. Response will include complete response (CR)/CR with incomplete marrow recovery (CRi), partial response (PR), and nodular PR.
Objective response rate with PR-L as determined by IRC
The percentage of participants with response as determined according to 2018 iwCLL guidelines. Response will include CR/CRi, PR, and nodular PR.
Objective response rate with and without PR-L as determined by investigator
The percentage of participants with response as determined according to 2018 iwCLL guidelines. Response will include CR/CRi, PR, and nodular PR.
Duration of response as determined by IRC and by investigator
Time from the date of the first response to the date of documented progressive disease or death due to any cause, whichever is earlier
Progression-free survival as determined by IRC and by investigator
Time from the date of the first dose of study drug to the date of documented progressive disease or death due to any cause, whichever is earlier
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