Clinical Trials in Spain / NCT05131022
Recruiting
Phase 1
A Study of NX-5948 in Adults With Relapsed/Refractory B-cell Malignancies
NCT05131022 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Chronic Lymphocytic Leukemia (CLL)Small Lymphocytic Lymphoma (SLL)Diffuse Large B Cell Lymphoma (DLBCL)Follicular Lymphoma (FL)Mantle Cell Lymphoma (MCL)Marginal Zone Lymphoma (MZL)Waldenstrom Macroglobulinemia (WM)Primary Central Nervous System Lymphoma (PCNSL)Secondary Central Nervous System Lymphoma (SCNSL)
Study summary
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.
Eligibility
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).
Primary outcome measure(s)
- Number of participants with protocol specified dose-limiting toxicities — Up to 24 months
Phase 1a - To establish the maximum tolerated dose and/or recommended Phase 1b dose(s) — Up to 24 months
Phase 1a - To evaluate the anti-tumor activity of NX-5948 in the dose levels selected for Phase 1b safety expansion based on overall response rate (ORR) as assessed by Investigator — Up to 3 years
Phase 1b Part 1 - Number of participants with treatment-emergent adverse events (TEAEs); Grade 3, 4, 5 TEAEs, serious adverse events (SAEs), TEAEs leading to study drug discontinuation, deaths due to TEAEs, and all deaths — Up to 6 years
Phase 1a / Phase 1b Part 1 - To further evaluate the anti-tumor activity of NX-5948 in patients with CLL/SLL at the dose identified in Phase 1b Part 1 based on overall response rate (ORR) as assessed by Investigator — Up to 3 years
Phase 1b Part 2
Trial sites (62)
| Facility | City | Region | Status |
|---|---|---|---|
| City of Hope | Duarte | California | Recruiting |
| University of California, San Francisco | San Francisco | California | Recruiting |
| Colorado Blood Cancer Institute | Denver | Colorado | Recruiting |
| Yale Cancer Center | New Haven | Connecticut | Recruiting |
| University of Miami | Miami | Florida | Recruiting |
| Florida Cancer Specialists | Sarasota | Florida | Recruiting |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | Recruiting |
| Northwestern University | Chicago | Illinois | Recruiting |
| National Institute of Health | Bethesda | Maryland | Recruiting |
| Cayuga Medical Center | Ithaca | New York | Withdrawn |
| Memorial Sloan Kettering Cancer Center | New York | New York | Active Not Recruiting |
| Duke University Medical Center | Durham | North Carolina | Recruiting |
| University of Cincinnati Medical Center | Cincinnati | Ohio | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | Recruiting |
| University of Pennsylvania, Abramson Cancer Center | Philadelphia | Pennsylvania | Recruiting |
| MD Anderson Cancer Center | Houston | Texas | Recruiting |
| Huntsman Cancer Institute | Salt Lake City | Utah | Withdrawn |
| Medical College of Wisconsin | Milwaukee | Wisconsin | Recruiting |
| CHU Angers | Angers | France | Recruiting |
| Hôpital Avicenne | Bobigny | France | Recruiting |
| CHU de Nantes | Nantes | France | Recruiting |
| CHU Bordeaux | Pessac | France | Recruiting |
| CHU de Poitiers | Poitiers | France | Recruiting |
| Institut Curie-Site Saint-Cloud | Saint-Cloud | France | Recruiting |
| CHRU de Nancy | Vandœuvre-lès-Nancy | France | Recruiting |
| IRCCS - AOU di Bologna | Bologna | Italy | Withdrawn |
| ASST Spedali Civili Brescia | Brescia | Italy | Withdrawn |
| IRCCS Ospedale San Raffaele - Università Vita-Salute San Raffaele di Milano | Milan | Italy | Recruiting |
| IRCCS Ospedale San Raffaele | Milan | Italy | Recruiting |
| Fondazione Policlinico Universitario A. Gemelli IRCCS | Rome | Italy | Recruiting |
| University Medical Center Groningen | Groningen | Netherlands | Withdrawn |
| Radboud University Medical Center | Nijmegen | Netherlands | Recruiting |
| Erasmus MC | Rotterdam | Netherlands | Recruiting |
| University Medical Center Utrecht | Utrecht | Netherlands | Recruiting |
| AidPort sp. Zo.o | Skórzewo | Greater Poland Voivodeship | Recruiting |
| Pratia MCM | Krakow | Lesser Poland Voivodeship | Recruiting |
| University Clinical Hostpital in Wroclaw | Wroclaw | Lower Silesian Voivodeship | Recruiting |
| Pratia MTZ | Warsaw | Masovian Voivodeship | Recruiting |
| National Institute of Oncology Warszawa | Warsaw | Masovian Voivodeship | Recruiting |
| Pratia Onkologia Katowice | Katowice | Silesian Voivodeship | Recruiting |
+ 22 more sites — see the full list on the official registry below.
Other trials for the same condition
A Study of Acalabrutinib Plus Venetoclax and Rituximab in Participants With Treatment Naïve Mantle Cell Lymphoma
Active, not recruiting
An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05131022 on ClinicalTrials.gov ↗ ← All trials in Spain