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

NCT03952078 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: CPI-818-001
• Study Type: interventional
• Target: 151
• Locations: 4 countries
• Sites: 22

Brief 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.

Conditions

T-cell Lymphoma

Keywords

CTCL; PTCL

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• 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.

• 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.

• 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

• 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.

• 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.

Study Arms (2)

CPI-818 Dose Escalation

EXPERIMENTAL

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.

Drug: CPI-818

CPI-818 Dose Expansion phase

EXPERIMENTAL

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.

Drug: CPI-818

Interventions

CPI-818 DRUG

Interleukin-2 inducible T-cell Kinase Inhibitor

CPI-818 Dose Escalation; CPI-818 Dose Expansion phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Corvus Pharmaceuticals, Inc.: lead

Study Sites (22)

Stanford University

Palo Alto, California, 94304, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Concord Repatriation General Hospital

Concord, New South Wales, 2139, Australia

Location

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Epworth Healthcare

Melbourne, Victoria, 3002, Australia

Location

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100052, China

Location

Beijing Boren Hospital

Beijing, Beijing Municipality, 100142, China

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Shanghai East Hospital

Pudong, Shanghai Municipality, 200136, China

Location

Henan Cancer Hospital

Henan, Zhengzhou, 450003, China

Location

Seoul National University Hospital

Seoul, Gyeonggido, 03080, South Korea

Location

Asan Medical Center

Seoul, Gyeonggido, 05505, South Korea

Location

Samsung Medical Center

Seoul, Gyeonggido, 06351, South Korea

Location

Seoul St. Mary's Hospital

Seoul, Gyeonggido, 06591, South Korea

Location

Inje University Busan-Paik Hospital

Busan, 47392, South Korea

Location

Pusan National University Hospital

Busan, 49241, South Korea

Location

Gachon University

Incheon, 21565, South Korea

Location

MeSH Terms

Conditions

Lymphoma, T-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Suresh Mahabhashyam, MD, MPH

  Corvus Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 16, 2019
• Study Start: May 3, 2019
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: April 16, 2025

Record last verified: 2025-04

Locations

AU (4); US (6); CN (5); KR (7)