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


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Trial ID: NCT03952078


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.

Official Title

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

Stanford Investigator(s)

Youn H Kim, MD
Youn H Kim, MD

The Joanne and Peter Haas, Jr., Professor for Cutaneous Lymphoma Research and Professor, by courtesy, of Medicine (Oncology)


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

   - Concomitant use of strong inhibitors or inducers of CYP3A.


drug: CPI-818


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Elle Kim

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