Actively Recruiting
Open-Label Dose Escalation and Expansion Trial of Emavusertib (CA-4948) in Adults with Relapsed or Refractory Primary Central Nervous System Lymphoma
Led by Curis, Inc. · Updated on 2026-04-16
152
Participants Needed
45
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, how the body processes the drugs (pharmacokinetics), and the anti-cancer effects of oral emavusertib alone or combined with ibrutinib in adults with relapsed or refractory blood cancers, specifically primary central nervous system lymphoma (PCNSL). This multi-center, open-label trial includes several parts to study these treatments in different patient groups, including those who have progressed after previous therapies and those new to certain treatments. The study is sponsored by Curis, Inc. and spans from initial dose-finding to assessing response rates and safety. The trial is conducted in four parts. Part A1 involved increasing doses of emavusertib alone to find a safe dose. Part A2 tested emavusertib combined with ibrutinib at specified doses. Part B includes two groups of participants with PCNSL who progressed on a Bruton tyrosine kinase inhibitor (BTKi), receiving emavusertib at either 100 mg or 200 mg twice daily plus ibrutinib daily in 28-day cycles. Part C involves three groups of participants with PCNSL new to BTKi treatment, randomly assigned to emavusertib alone, ibrutinib alone, or their combination, with treatment cycles of 28 days continuing as tolerated. Participants will take study drugs orally and undergo regular monitoring for safety and treatment effects. Researchers will evaluate side effects, determine maximum tolerated doses, and measure response rates and durations. Pharmacokinetic profiles of both drugs will be assessed over months. The trial includes assessments of tumor progression and survival, with follow-ups lasting up to several years. Participants' health status and response to treatment will be carefully tracked throughout the study.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 18 years or older
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Histopathologically confirmed diagnosis of primary central nervous system lymphoma (PCNSL), with typical imaging if biopsy not available
- For parenchymal lesions, presence of at least one measurable target lesion between 10 mm and 40 mm on brain MRI or CT scan within 28 days prior to treatment
- For leptomeningeal involvement, cerebrospinal fluid analysis with or without spine imaging within 28 days prior to treatment
You will not qualify if you...
- Participants with only intraocular PCNSL without brain lesion or cerebrospinal fluid involvement
- Participants with T-cell lymphoma, systemic lymphoma, or non-CNS lymphoma metastatic to the CNS
- Evidence of systemic lymphoma confirmed by PET or CT scan of chest, abdomen, and pelvis
- Prior history of malignancies other than lymphoma (except certain skin or cervical/breast cancers) unless disease-free for 3 or more years
- Active malignancy other than PCNSL requiring systemic therapy
- Previous Bruton tyrosine kinase inhibitor (BTKi) treatment in Part C
- History of severe rhabdomyolysis without full recovery
- Need for urgent therapy due to uncontrolled tumor mass or edema
- External beam radiation to the CNS within 28 days prior to treatment
- Recent use of investigational drugs within 28 days or 5 half-lives before treatment
- Allogeneic hematopoietic stem cell transplant within 60 days prior to treatment or ongoing graft-versus-host disease requiring immunosuppressive medication adjustments
- Prior systemic anti-cancer treatments within 14 days or 5 half-lives before treatment (with exceptions for certain BTKi use in Part B only)
- History of hypersensitivity or anaphylaxis to emavusertib, ibrutinib, or their components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 66 months
Participants receive oral emavusertib alone or in combination with oral ibrutinib in repeated 28-day treatment cycles to evaluate safety, tolerability, and efficacy.
Repeated visits every 28 days during treatment cycles
Trial Site Locations
Total: 45 locations
1
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
Actively Recruiting
2
Mayo Clinic
Phoenix, Arizona, United States, 85054
Completed
3
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
4
Providence St. John's Health Center
Santa Monica, California, United States, 90404
Actively Recruiting
5
UCLA Department of Medicine - Hematology/Oncology
Santa Monica, California, United States, 90404
Withdrawn
6
Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, United States, 06510
Completed
7
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
8
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
9
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
10
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
11
Fred and Pamela Buffett Cancer Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
12
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Completed
13
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14263
Actively Recruiting
14
Mt Sinai
New York, New York, United States, 10029
Actively Recruiting
15
Columbia University Irving Medical Center
New York, New York, United States, 10032
Withdrawn
16
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
17
Duke University Medical Center, Duke Cancer Center
Durham, North Carolina, United States, 27710
Actively Recruiting
18
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
19
Providence Neurological Specialties West
Portland, Oregon, United States, 97225
Actively Recruiting
20
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Completed
21
UPMC Hilman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
22
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920
Completed
23
UT Southwestern Medical Center
Dallas, Texas, United States, 75235
Active, Not Recruiting
24
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
25
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
26
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Completed
27
University of Washington Medical Center
Seattle, Washington, United States, 98195
Actively Recruiting
28
Všeobecná fakultní nemocnice v Praze
Prague, Czechia
Actively Recruiting
29
Institut Bergonie
Bordeaux, France
Actively Recruiting
30
Hopital de la Timone
Marseille, France
Actively Recruiting
31
Hospital Pitie Salpetriere
Paris, France
Actively Recruiting
32
Institut Curie Hospital
Paris, France
Actively Recruiting
33
Hematology Department Soroka UMC / Heanatology Department
Beersheba, Israel
Actively Recruiting
34
Rambam Medical Center
Haifa, Israel
Actively Recruiting
35
Hadassah Medical Center / Ein-Carem
Jerusalem, Israel
Actively Recruiting
36
Università di Torino Croce e Carle
Cuneo, Italy
Actively Recruiting
37
SODc Ematologia Azienda Ospedaliera Universitaria Careggi
Florence, Italy
Actively Recruiting
38
IRST - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Italy
Actively Recruiting
39
IRCCS San Raffaele Scientific Institute
Milan, Italy
Actively Recruiting
40
Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz
Gdansk, Poland
Actively Recruiting
41
Oddzial Kliniczny Hematologii
Krakow, Poland
Withdrawn
42
NarodowyInstytutu Onkologii im. Marii Sklodowskiej-Curie-Panstwowy Instytutu Badawczy
Warsaw, Poland
Actively Recruiting
43
University Hospital Vall d'Hebron
Barcelona, Spain
Actively Recruiting
44
MD Anderson Cancer Center Madrid
Madrid, Spain
Actively Recruiting
45
Hospital Universitario Virgen del Rocio
Seville, Spain
Actively Recruiting
Research Team
A
Ahmed Hamdy, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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