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)

ClinicalTrials.gov ID: NCT03328078

Public ClinicalTrials.gov record NCT03328078. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 6, 2026, 1:42 PM EDT

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Official title

An Open-Label, Dose Escalation and Dose Expansion Trial Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Orally Administered CA-4948 in Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT03328078
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: Curis, Inc.; Industry
Enrollment: 152 participants

Conditions and interventions

Conditions

Interventions

Emavusertib Drug
Ibrutinib Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Dec 27, 2017
Primary completion: Jul 31, 2026
Completion: Sep 30, 2026
Last update posted: Apr 15, 2026

2017 – 2026

United States locations

U.S. sites: 27
U.S. states: 18
U.S. cities: 22

Facility	City	State	ZIP	Site status
St. Joseph's Hospital and Medical Center	Phoenix	Arizona	85013	Recruiting
Mayo Clinic	Phoenix	Arizona	85054	Completed
City of Hope	Duarte	California	91010	Recruiting
Providence St. John's Health Center	Santa Monica	California	90404	Recruiting
UCLA Department of Medicine - Hematology/Oncology	Santa Monica	California	90404	Withdrawn
Smilow Cancer Hospital at Yale-New Haven	New Haven	Connecticut	06510	Completed
Mayo Clinic	Jacksonville	Florida	32224	Recruiting
Northwestern Memorial Hospital	Chicago	Illinois	60611	Recruiting
Dana Farber Cancer Institute	Boston	Massachusetts	02215	Recruiting
Mayo Clinic	Rochester	Minnesota	55905	Recruiting
Fred and Pamela Buffett Cancer Center	Omaha	Nebraska	68198	Recruiting
Hackensack University Medical Center	Hackensack	New Jersey	07601	Completed
Roswell Park Comprehensive Cancer Center	Buffalo	New York	14263	Recruiting
Mt Sinai	New York	New York	10029	Recruiting
Columbia University Irving Medical Center	New York	New York	10032	Withdrawn
Memorial Sloan Kettering Cancer Center	New York	New York	10065	Recruiting
Duke University Medical Center, Duke Cancer Center	Durham	North Carolina	27710	Recruiting
Cleveland Clinic	Cleveland	Ohio	44195	Recruiting
Providence Neurological Specialties West	Portland	Oregon	97225	Recruiting
Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	19104	Completed
UPMC Hilman Cancer Center	Pittsburgh	Pennsylvania	15232	Recruiting
University of Tennessee Medical Center	Knoxville	Tennessee	37920	Completed
UT Southwestern Medical Center	Dallas	Texas	75235	Active, not recruiting
The University of Texas MD Anderson Cancer Center	Houston	Texas	77030	Recruiting
Huntsman Cancer Institute, University of Utah	Salt Lake City	Utah	84112	Recruiting
Swedish Cancer Institute	Seattle	Washington	98104	Completed
University of Washington Medical Center	Seattle	Washington	98195	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 18 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT03328078, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Apr 15, 2026 · Synced Sep 6, 2026

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The complete protocol, eligibility criteria, and contact information for NCT03328078 live on ClinicalTrials.gov.

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