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New treatment option for Chronic Lymphocytic Leukemia (CLL)
Official title A Study of NX-5948 in Adults With Relapsed/Refractory B-cell Malignancies
ClinicalTrials.gov ID: NCT05131022
What this study is testing
What is NX-5948?
NX-5948 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic lymphocytic leukemia (cll).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a first-in-human Phase 1a/1b multicenter, open-label study designed to evaluate the safety and anti-cancer activity of NX-5948 in patients with advanced B-cell malignancies.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years
- Patients in Phase 1a (Dose Escalation) must have histologically confirmed R/R CLL, SLL, DLBCL (subgroups include Richter-transformed DLBCL, germinal...
- Patients in Phase 1a must meet the following: o For non-PCNSL indications, received at least 2 prior lines of therapy and have no other available...
- Patients in Phase 1b (Safety and Cohort Expansion) must have 1 of the following histologically documented B-cell malignancies, must meet criteria for...
- Measurable disease per response criteria specific to the malignancy.
You likely can't join if
- Known or suspected active prolymphocytic leukemia or Richter's transformation to Hodgkin's lymphoma prior to study enrollment
- Prior treatment for the indication under study for anti-cancer intent that includes:
- Radiotherapy within 2 weeks of planned start of study drug (excluding limited palliative radiation).
- Prior systemic chemotherapy within 2 weeks of planned start of study drug.
- Prior monoclonal antibody therapy within 4 weeks of planned start of study drug, except for patients enrolling in Cohort 16 (CLL with secondary...
- Prior small molecule therapy within 2 weeks or 5 half-lives (whichever is shorter) of planned start of study drug.
See the full eligibility criteria
- Age ≥18 years
- Patients in Phase 1a (Dose Escalation) must have histologically confirmed R/R CLL, SLL, DLBCL (subgroups include Richter-transformed DLBCL, germinal center B-cell type, activated B-cell type, high-grade B-cell lymphoma...
- Patients in Phase 1a must meet the following: o For non-PCNSL indications, received at least 2 prior lines of therapy and have no other available therapies known to provide clinical benefit. For PCNSL, received at least...
- Patients in Phase 1b (Safety and Cohort Expansion) must have 1 of the following histologically documented B-cell malignancies, must meet criteria for systemic treatment, and must have received prior therapies and/or...
- Measurable disease per response criteria specific to the malignancy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (0-2 for patients with PCNSL and secondary CNS involvement).
- Adequate organ and bone marrow function Key
- Known or suspected active prolymphocytic leukemia or Richter's transformation to Hodgkin's lymphoma prior to study enrollment
- Prior treatment for the indication under study for anti-cancer intent that includes:
- Radiotherapy within 2 weeks of planned start of study drug (excluding limited palliative radiation).
- Prior systemic chemotherapy within 2 weeks of planned start of study drug.
- Prior monoclonal antibody therapy within 4 weeks of planned start of study drug, except for patients enrolling in Cohort 16 (CLL with secondary wAIHA) where a 16-week washout period is required.
- Prior small molecule therapy within 2 weeks or 5 half-lives (whichever is shorter) of planned start of study drug.
- Autologous or allogeneic stem cell transplant within 100 days prior to planned start of study drug.
- Chimeric antigen receptor (CAR) T-cell therapy within 100 days prior to start of study drug (within 60 days prior to start of study drug for Phase 1b).
- Use of systemic corticosteroids outside of dosing limits described below and within 7 days prior to initiation of study treatment excepting those used as prophylaxis for radio diagnostic contrast. Patients with...
- Use of systemic immunosuppressive drugs other than systemic corticosteroids for any medical condition within 60 days prior to first dose of study drug
- Previously treated with a BTK degrader
- Active, uncontrolled autoimmune hemolytic anemia (except for patients enrolling in Cohort 16) or active, uncontrolled autoimmune thrombocytopenia.
- Patient has any of the following within 6 months of planned start of study drug:
- Myocardial infarction, unstable angina, unstable symptomatic ischemic heart disease, or placement of a coronary arterial stent
- Uncontrolled atrial fibrillation or other clinically significant arrhythmias, conduction abnormalities, or New York Heart Association (NYHA) class III or IV heart failure
- Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), stroke, or intracranial hemorrhage
- Any other significant cardiac condition (e.g., pericardial effusion, restrictive cardiomyopathy, severe untreated valvular stenosis, severe congenital heart disease, or persistent uncontrolled hypertension defined as...
- Bleeding diathesis, or other known risk for acute blood loss.
- History of Grade ≥ 2 hemorrhage within 28 days of planned start of study drug.
- Active known concurrent malignancy or malignancy other than the one under study within the past 3 years. (Exceptions include, but are not limited to, patients with more recent history of basal or squamous cell skin...
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- San Francisco, California, United States
- Denver, Colorado, United States
- New Haven, Connecticut, United States
- Miami, Florida, United States
- Sarasota, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Bethesda, Maryland, United States
- Ithaca, New York, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Milwaukee, Wisconsin, United States
- Angers, France
- Bobigny, France
+ 37 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; San Francisco, California, United States; Denver, Colorado, United States; New Haven, Connecticut, United States; Miami, Florida, United States; Sarasota, Florida, United States and 51 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.