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

NCT ID: NCT03952078

Last Updated: 2025-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-03

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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T-cell Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CPI-818 Dose Escalation

Participants will receive CPI-818 capsule, orally, twice per day at an assigned dose, till disease progression, complete response or remission (CR) for \>2 months or if dose determined to be unsafe.

Group Type EXPERIMENTAL

CPI-818

Intervention Type DRUG

Interleukin-2 inducible T-cell Kinase Inhibitor

CPI-818 Dose Expansion phase

Participants with different T-cell lymphoma sub-types will receive CPI-818 capsules at the specific dose selected from the Dose escalation phase of the study.

CPI-818 capsules at the selected dose will be taken orally, twice per day until disease progression or CR for \> 2 months.

Group Type EXPERIMENTAL

CPI-818

Intervention Type DRUG

Interleukin-2 inducible T-cell Kinase Inhibitor

Interventions

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CPI-818

Interleukin-2 inducible T-cell Kinase Inhibitor

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Corvus Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Suresh Mahabhashyam, MD, MPH

Role: STUDY_DIRECTOR

Corvus Pharmaceuticals

Locations

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Stanford University

Palo Alto, California, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Site Status

Liverpool Hospital

Liverpool, New South Wales, Australia

Site Status

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Site Status

Epworth Healthcare

Melbourne, Victoria, Australia

Site Status

Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Site Status

Beijing Boren Hospital

Beijing, Beijing Municipality, China

Site Status

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status

Shanghai East Hospital

Pudong, Shanghai Municipality, China

Site Status

Henan Cancer Hospital

Henan, Zhengzhou, China

Site Status

Seoul National University Hospital

Seoul, Gyeonggido, South Korea

Site Status

Asan Medical Center

Seoul, Gyeonggido, South Korea

Site Status

Samsung Medical Center

Seoul, Gyeonggido, South Korea

Site Status

Seoul St. Mary's Hospital

Seoul, Gyeonggido, South Korea

Site Status

Inje University Busan-Paik Hospital

Busan, , South Korea

Site Status

Pusan National University Hospital

Busan, , South Korea

Site Status

Gachon University

Incheon, , South Korea

Site Status

Countries

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United States Australia China South Korea

Other Identifiers

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CPI-818-001

Identifier Type: -

Identifier Source: org_study_id

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