OncoMatch/Clinical Trials/NCT03328078
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)
Is NCT03328078 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Emavusertib and Ibrutinib for relapsed hematologic malignancy.
Treatment: Emavusertib · Ibrutinib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Multiple Myeloma
Myelodysplastic Syndrome
Chronic Lymphocytic Leukemia
Primary Central Nervous System Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: BTK inhibitor
Exception: Part C only
Previous BTKi treatment (Part C only)
Cannot have received: external beam radiation therapy to the CNS
Received external beam radiation therapy to the CNS within 28 days prior to Cycle 1 Day 1
Cannot have received: investigational drug
Received prior investigational drugs (including treatment in clinical research, unapproved combination products, and new dosage forms) within 28 days or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1
Cannot have received: allogeneic hematopoietic stem cell transplant
allogeneic hematopoietic stem cell transplant (HSCT) within 60 days prior to Cycle 1 Day 1
Cannot have received: systemic anti-cancer treatment
Exception: ibrutinib or other BTKi for Part B only, which may be continued until the day before Cycle 1 Day 1
Any prior systemic anti-cancer treatment such as chemotherapy, immunomodulatory drug therapy, etc., received within 14 days or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1 (with the exception of ibrutinib or other BTKi for Part B only, which may be continued until the day before Cycle 1 Day 1)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- St. Joseph's Hospital and Medical Center · Phoenix, Arizona
- Mayo Clinic · Phoenix, Arizona
- City of Hope · Duarte, California
- Providence St. John's Health Center · Santa Monica, California
- UCLA Department of Medicine - Hematology/Oncology · Santa Monica, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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