A Dose Escalation Study Evaluating CPI-818 in Relapsed/Refractory T-Cell Lymphoma
NCT ID: NCT03952078
Last Updated: 2025-04-16
Study Results
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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ACTIVE_NOT_RECRUITING
PHASE1
151 participants
INTERVENTIONAL
2019-05-03
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
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.
CPI-818
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.
CPI-818
Interleukin-2 inducible T-cell Kinase Inhibitor
Interventions
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CPI-818
Interleukin-2 inducible T-cell Kinase Inhibitor
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Corvus Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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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
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
Countries
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Other Identifiers
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CPI-818-001
Identifier Type: -
Identifier Source: org_study_id
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