CA-4948-101: Open-Label, Dose Escalation and Expansion Trial of Emavusertib (CA-4948) in Relapsed or Refractory Primary Central Nervous System Lymphoma (R/R PCNSL)
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This is a multi-center, open-label study to evaluate the safety, pharmacokinetics (PK), and anti-cancer activity of oral administration of emavusertib alone or in combination with ibrutinib in adult participants with relapsed or refractory (R/R) hematologic malignancies. This trial will be completed in four parts. In Part A1, emavusertib will be evaluated first in a dose escalating monotherapy setting to establish the safety and tolerability (complete). In Part A2, emavusertib will be evaluated in combination with ibrutinib at 560 milligrams (mg) once daily (QD) or 420 mg QD as indicated by disease (Part A2 complete). Part B will comprise 2 cohorts to assess safety and efficacy of emavusertib in combination with ibrutinib in participants with R/R primary central nervous system lymphoma (PCNSL) who have directly progressed on a bruton tyrosine kinase inhibitor (BTKi). In this part of the study, emavusertib will be dosed at 100 mg or 200 mg twice daily (BID) in combination with ibrutinib in 28-day treatment cycles. Part C will comprise 3 treatment arms in the second-line setting to assess the efficacy and safety of emavusertib monotherapy, ibrutinib monotherapy, and emavusertib in combination with ibrutinib in participants with R/R PCNSL who are naïve to BTKi treatment. In this part of the study, eligible second-line participants with R/R PCNSL who are naïve to BTKi treatment will be randomized 1:1:1 to 1 of 3 treatment arms: (1) emavusertib 200 mg BID, (2) ibrutinib 560 mg QD, or (3) emavusertib 200 mg BID in combination with ibrutinib 560 mg QD.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Spodziewana długość życia co najmniej 3 miesiące
- •Dobrze zachowany stan ogólny (ECOG 0-2)
- •Potwierdzona diagnoza chłoniaka mózgu (PCNSL)
- •Widoczne objawy progresji nowotworu na obrazach (MRI lub CT) wykonanych w ciągu 28 dni przed rozpoczęciem leczenia
✗ Disqualifies
- •Chłoniak tylko w oku bez zmian w mózgu lub płynie mózgowo-rdzeniowym
- •Chłoniak z komórek T
- •Chłoniak poza ośrodkowym układem nerwowym
- •Dowód na obecność chłoniaka w innych częściach ciała (musi być wykonane badanie PET lub CT)
- •Historia innego nowotworu przed leczeniem chłoniaka (oprócz raka skóry lub raka szyjki macicy)
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- October 6, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (45)
St. Joseph's Hospital and Medical Center
Phoenix, United States
Mayo Clinic
Phoenix, United States
City of Hope
Duarte, United States
Providence St. John's Health Center
Santa Monica, United States
UCLA Department of Medicine - Hematology/Oncology
Santa Monica, United States
Smilow Cancer Hospital at Yale-New Haven
New Haven, United States
Mayo Clinic
Jacksonville, United States
Northwestern Memorial Hospital
Chicago, United States
Dana Farber Cancer Institute
Boston, United States
Mayo Clinic
Rochester, United States
Fred and Pamela Buffett Cancer Center
Omaha, United States
Hackensack University Medical Center
Hackensack, United States
Roswell Park Comprehensive Cancer Center
Buffalo, United States
Mt Sinai
New York, United States
Columbia University Irving Medical Center
New York, United States
Memorial Sloan Kettering Cancer Center
New York, United States
Duke University Medical Center, Duke Cancer Center
Durham, United States
Cleveland Clinic
Cleveland, United States
Providence Neurological Specialties West
Portland, United States
Hospital of the University of Pennsylvania
Philadelphia, United States
UPMC Hilman Cancer Center
Pittsburgh, United States
University of Tennessee Medical Center
Knoxville, United States
UT Southwestern Medical Center
Dallas, United States
The University of Texas MD Anderson Cancer Center
Houston, United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, United States
Swedish Cancer Institute
Seattle, United States
University of Washington Medical Center
Seattle, United States
Všeobecná fakultní nemocnice v Praze
Prague, Czechia
Institut Bergonie
Bordeaux, France
Hopital de la Timone
Marseille, France
Hospital Pitie Salpetriere
Paris, France
Institut Curie Hospital
Paris, France
Hematology Department Soroka UMC / Heanatology Department
Beersheba, Israel
Rambam Medical Center
Haifa, Israel
Hadassah Medical Center / Ein-Carem
Jerusalem, Israel
Università di Torino Croce e Carle
Cuneo, Italy
SODc Ematologia Azienda Ospedaliera Universitaria Careggi
Florence, Italy
IRST - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Italy
IRCCS San Raffaele Scientific Institute
Milan, Italy
Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz
Gdansk, Poland
Oddzial Kliniczny Hematologii
Krakow, Poland
NarodowyInstytutu Onkologii im. Marii Sklodowskiej-Curie-Panstwowy Instytutu Badawczy
Warsaw, Poland
University Hospital Vall d'Hebron
Barcelona, Spain
MD Anderson Cancer Center Madrid
Madrid, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
Trial contact
Ahmed Hamdy, MD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/7/2026.
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