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

Trial Status: Active

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.

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.

California

Palo Alto
Stanford Cancer Institute Palo Alto
Status: ACTIVE
San Francisco
UCSF Medical Center-Mount Zion
Status: APPROVED
Contact: Helen Diller Family Comprehensive Cancer Center
Phone: 877-827-3222

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: ACTIVE

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE

Nebraska

Omaha
University of Nebraska Medical Center
Status: IN_REVIEW

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: IN_REVIEW

New Jersey

Hackensack
Hackensack University Medical Center
Status: ACTIVE

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE

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.

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Corvus Pharmaceuticals, Inc.

  • Primary ID CPI-818-001
  • Secondary IDs NCI-2019-03933
  • Clinicaltrials.gov ID NCT03952078