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NCT Number: NCT03952078

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Concord Repatriation General Hospital, Concord, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CPI-818

Drug

Interleukin-2 inducible T-cell Kinase Inhibitor

Primary outcomes

  1. Incidence, nature, and severity of adverse events following treatment with CPI 818 to establish the safety and tolerability with increasing dose

    Time frame: First dose until 30 days after treatment stop

  2. 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

    Time frame: Up to approximately 21 days after first dose

Secondary outcomes

  1. Area under the curve (AUC) of CPI-818 in blood samples to evaluate the pharmacokinetic profile of CPI 818

    Time frame: 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.

  2. Maximum serum concentration (Cmax) of CPI-818 in blood samples to evaluate the pharmacokinetic profile of CPI 818

    Time frame: 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.

  3. 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

    Time frame: From start of treatment through end of study treatment, up to approximately 24 months

  4. Evaluate total percentage of tumor gene expression in post-treatment blood and tumor samples to evaluate pharmacodynamic changes with treatment.

    Time frame: 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.

  5. Evaluate overall percentage of malignant cells in post-treatment blood and tumor samples to evaluate pharmacodynamic changes with treatment.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Corvus Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
May 16, 2019
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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