A Dose Escalation Study Evaluating CPI-818 in Relapsed / Refractory T-Cell Lymphoma
- Adult subjects age ≥18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Histologically confirmed evidence of T-cell lymphoma
- Measurable disease.
- Adequate organ function.
- At least 2 standard therapies for advanced or recurrent disease or had a disease for which there is no more than one established therapy.
- Treatment with systemic immunosuppressive medication.
- History of allogeneic hematopoietic stem cell transplantation.
- History of primary immunodeficiency, solid organ transplantation.
- History of opportunistic infection within 180 days of starting study drug.
- Females who are pregnant, lactating, or intend to become pregnant
- History of invasive prior malignancy that required systemic therapy within last 3 years.
- Concomitant use of strong inhibitors or inducers of CYP3A.
This is a Phase 1/1b, open-label, first in human study of CPI-818, an oral interleukin-2-inducible tyrosine kinase (ITK) inhibitor for the treatment of relapsed/refractory (R/R) T-cell lymphoma.. This trial will study the safety, tolerability, and anti-tumor activity of CPI-818 as a single drug. This trial is composed of dose escalation and dose expansion cohorts.
Trial Phase Phase I
Trial Type Treatment
Corvus Pharmaceuticals, Inc.
- Primary ID CPI-818-001
- Secondary IDs NCI-2019-03933
- Clinicaltrials.gov ID NCT03952078