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 T-cell lymphoma. This trial will study the safety, tolerability, and anti-tumor activity of CPI-818 as a single drug.
Dr Dejan Radeski
Corvus Pharmaceuticals, Inc.
CPI 818 is a new tablet treatment which targets the internal machinery of the cancerous T-cell. In Western Australia the first patients in the world are being treated with this medicine and people who are eligible for this clinical trial are those with T-cell lymphoma which has persisted or come back after two different combinations of chemotherapy.
Include, but not limited to, the following:
- 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.