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

NCT03952078 · tracked via the Priya Life Science USA tracker

Sponsor

Corvus Pharmaceuticals, Inc.

Phase

Phase 1

Started

2019-05-03

Last updated

2025-04-16

Condition(s) studied

T-cell Lymphoma

Investigational drug(s) / intervention(s)

CPI-818

CPI-818: Interleukin-2 inducible T-cell Kinase Inhibitor

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Incidence, nature, and severity of adverse events following treatment with CPI 818 to establish the safety and tolerability with increasing dose — First dose until 30 days after treatment stop
Incidence and nature of dose limiting toxicities (DLTs) of CPI 818 to establish either the maximum tolerated dose (MTD) or the maximum administered dose (MAD) of CPI 818 — Up to approximately 21 days after first dose

Trial sites (22)

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

More Corvus Pharmaceuticals, Inc. trials in the USA

Study to Evaluate Soquelitinib in Participants With Moderate to Severe AD Recruiting

Safety and Efficacy of Soquelitinib in Adults With Hidradenitis Suppurativa Starting soon

Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma Recruiting

Other trials for the same condition

Phase 1 Trial of ST-001 nanoFenretinide in Relapsed/Refractory T-cell Non-Hodgkin Lymphoma Recruiting

BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20) Recruiting

Sample Collection for Ongoing Research and Product Evaluation Study - Non-Hodgkin Lymphoma (SCORE-NHL) Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03952078 on ClinicalTrials.gov ↗ ← All trials in the USA