A Study of NX-5948 in Adults With Relapsed/Refractory B-cell Malignancies
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests NX-5948 in people for the first time to learn about its safety and how well it fights cancer. It is for adults with advanced B-cell cancers that came back or did not respond to treatment. B cells are a type of white blood cell.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You must be 18 or older.
- You must have a B-cell cancer allowed in the study, confirmed by a tissue test. These include certain leukemias and lymphomas, including some in the brain or spinal cord.
- For Phase 1a, you must have had at least 2 past courses of treatment and have no other available treatment known to help. If your lymphoma started in the brain or spinal cord, at least 1 past course is needed.
- For Phase 1b, you must need treatment that works throughout the body. Each group has its own rules about past treatments and cancer cell features.
- Your cancer must be measurable using the rules for your cancer type.
- You must be fully active or able to do light work. People with lymphoma in the brain or spinal cord may qualify with more limits on activity if they can still care for themselves.
- Your organs and bone marrow, which makes blood cells, must work well enough.
Who can't join
- You cannot join with known or suspected active prolymphocytic leukemia, or if your cancer changed into Hodgkin lymphoma through Richter's transformation.
- Recent cancer treatments may prevent you from joining. Waiting periods include 2 weeks for most radiation or chemotherapy, 4 weeks for antibody treatment, and up to 2 weeks for small-molecule drugs. Some exceptions apply; one group requires 16 weeks after antibody treatment.
- You cannot join within 100 days of a stem cell transplant or CAR T-cell therapy, which uses changed immune cells to fight cancer. The CAR T-cell waiting period is 60 days in Phase 1b. Past treatment with a BTK degrader also prevents joining.
- Recent use of steroids above the study's dose limits, or other drugs that weaken the immune system within 60 days, may prevent joining. Steroid rules differ for people with lymphoma in the brain or spinal cord.
- You cannot join with uncontrolled immune-system attacks on red blood cells or platelets, which help blood clot. One study group allows the red blood cell condition.
- Certain serious heart or blood vessel problems within the past 6 months prevent joining. These include heart attack, some abnormal heart rhythms, severe heart failure, blood clots, stroke, bleeding inside the skull, or uncontrolled high blood pressure.
- You cannot join with a bleeding disorder, another known risk of sudden blood loss, or moderate or worse bleeding within the past 28 days.
- Another active cancer, or another cancer within the past 3 years, may prevent joining. Some treated skin, bladder, breast, or cervical cancers are allowed if there is no sign of cancer left.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Key Inclusion 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 with MYC and BCL-2 and/or BCL-6 rearrangements, high-grade B-cell lymphomas NOS), FL, MCL, MZL (subtypes include EMZL, MALT, NMZL, SMZL), WM, or PCNSL. * 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 1 prior line of therapy * 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 molecular features based on details described for each cohort: CLL or SLL, DLBCL, MCL, FL, MZL, WM, or PCNSL/SCNSL. * 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 Exclusion Criteria: * 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: 1. Radiotherapy within 2 weeks of planned start of study drug (excluding limited palliative radiation). 2. Prior systemic chemotherapy within 2 weeks of planned start of study drug. 3. 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. 4. Prior small molecule therapy within 2 weeks or 5 half-lives (whichever is shorter) of planned start of study drug. 5. Autologous or allogeneic stem cell transplant within 100 days prior to planned start of study drug. 6. 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). 7. 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 PCNSL/SCNSL: no greater than 40 mg/day prednisone, or equivalent. Patients with PCNSL/SCNSL using greater than 20 mg/day prednisone, or equivalent, must be clinically stable at that dose for 7 days. All other diagnoses: no greater than 20 mg/day prednisone or equivalent. 8. Use of systemic immunosuppressive drugs other than systemic corticosteroids for any medical condition within 60 days prior to first dose of study drug 9. 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: 1. Myocardial infarction, unstable angina, unstable symptomatic ischemic heart disease, or placement of a coronary arterial stent 2. Uncontrolled atrial fibrillation or other clinically significant arrhythmias, conduction abnormalities, or New York Heart Association (NYHA) class III or IV heart failure 3. Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), stroke, or intracranial hemorrhage 4. 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 systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg despite optimal medical management) * 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 cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast may enroll if they have undergone curative therapy and have no evidence of disease).
Study sites (18)
CA
- City of Hope · Duarte, CA 91010More trials in Duarte
- University of California, San Francisco · San Francisco, CA 94143 · Study contact · HDFCCCClinicalTrials@ucsf.eduMore trials in San Francisco
CO
- Colorado Blood Cancer Institute · Denver, CO 80218More trials in Denver
CT
- Yale Cancer Center · New Haven, CT 06510More trials in New Haven
FL
- University of Miami · Miami, FL 33136More trials in Miami
- Florida Cancer Specialists · Sarasota, FL 34232More trials in Sarasota
GA
- Winship Cancer Institute of Emory University · Atlanta, GA 30322More trials in Atlanta
IL
- Northwestern University · Chicago, IL 60611More trials in Chicago
MD
- National Institute of Health · Bethesda, MD 20814More trials in Bethesda
NC
- Duke University Medical Center · Durham, NC 27705More trials in Durham
NY
- Cayuga Medical Center · Ithaca, NY 14850More trials in Ithaca
- Memorial Sloan Kettering Cancer Center · New York, NY 10065More trials in New York
OH
- University of Cincinnati Medical Center · Cincinnati, OH 45219More trials in Cincinnati
- Cleveland Clinic · Cleveland, OH 44195More trials in Cleveland
PA
- University of Pennsylvania, Abramson Cancer Center · Philadelphia, PA 19104More trials in Philadelphia
TX
- MD Anderson Cancer Center · Houston, TX 77030Ana Ayala · Study contact · 713-792-4254 · abayala@mdanderson.orgMore trials in Houston
UT
- Huntsman Cancer Institute · Salt Lake City, UT 84112More trials in Salt Lake City
WI
- Medical College of Wisconsin · Milwaukee, WI 53226More trials in Milwaukee