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

T-cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03952078
• Other study ID #: CPI-818-001
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: May 3, 2019
• Est. completion date: April 30, 2026

Study information

• Verified date: December 2023
• Source: Corvus Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 151
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• T-cell Lymphoma

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Corvus Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Australia,  China,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	Area under the curve (AUC) of CPI-818 in blood samples to evaluate the pharmacokinetic profile of CPI 818		Day 1, 2, 8, 15 of Cycle 1, Day 1 and 2 of Cycle 3, and Day 1 for all even number Cycles. Each Cycle is 21 days.
Secondary	Maximum serum concentration (Cmax) of CPI-818 in blood samples to evaluate the pharmacokinetic profile of CPI 818		Day 1, 2, 8, 15 of Cycle 1, Day 1 and 2 of Cycle 3, and Day 1 for all even number Cycles. Each Cycle is 21 days.
Secondary	Objective response rate per Laguno Classification for CTCL and Consensus Statement for Response for CTCL to assess the anti-tumor activity of CPI 818 in subjects with R/R T cell lymphoma		From start of treatment through end of study treatment, up to approximately 24 months
Secondary	Evaluate total percentage of tumor gene expression in post-treatment blood and tumor samples to evaluate pharmacodynamic changes with treatment.		Day 1, 2, 8, 15 of Cycle 1, Day 1 and 2 of Cycle 3, and Day 1 for all even number Cycles. Each Cycle is 21 days.
Secondary	Evaluate overall percentage of malignant cells in post-treatment blood and tumor samples to evaluate pharmacodynamic changes with treatment.		Day 1, 2, 8, 15 of Cycle 1, Day 1 and 2 of Cycle 3, and Day 1 for all even number Cycles. Each Cycle is 21 days.