A Dose Escalation Study Evaluating CPI-818 in Relapsed/Refractory T-Cell Lymphoma

A Phase 1/1b Dose-Escalation Trial Evaluating CPI-818, an Oral Interleukin-2-Inducible T-Cell Kinase Inhibitor, in Subjects With Relapsed/Refractory T-Cell Lymphoma

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 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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.