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

Running, not enrolling · Phase 1

Conditions studied: T-cell Lymphoma

In brief

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.

Key facts

Study ID

NCT03952078

Run by

Corvus Pharmaceuticals, Inc.

People needed

151

Starts

2019-05-03

Expected to finish

2026-04-30

Last updated by the study team

2025-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Stanford University — Palo Alto, California, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Washington University — St Louis, Missouri, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Ohio State University — Columbus, Ohio, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Concord Repatriation General Hospital — Concord, New South Wales, Australia
• Liverpool Hospital — Liverpool, New South Wales, Australia
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• Epworth Healthcare — Melbourne, Victoria, Australia
• Beijing Friendship Hospital — Beijing, Beijing Municipality, China
• Beijing Boren Hospital — Beijing, Beijing Municipality, China
• Beijing Cancer Hospital — Beijing, Beijing Municipality, China
• Shanghai East Hospital — Pudong, Shanghai Municipality, China
• Henan Cancer Hospital — Henan, Zhengzhou, China
• Seoul National University Hospital — Seoul, Gyeonggido, South Korea
• Asan Medical Center — Seoul, Gyeonggido, South Korea
• Samsung Medical Center — Seoul, Gyeonggido, South Korea
• Seoul St. Mary's Hospital — Seoul, Gyeonggido, South Korea
• Inje University Busan-Paik Hospital — Busan, South Korea
• Pusan National University Hospital — Busan, South Korea
• Gachon University — Incheon, South Korea

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.