Joint Clinical Trials Office

A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy and Safety of ITK Inhibitor Soquelitinib Versus Physician’s Choice Standard of Care Treatment (Selected Single Agent) in Participants with Relapsed/Refractory Peripheral T-cell Lymphoma

Clinical Trial Details

 This clinical trial is for men and women with returned (relapsed) and/or has not responded to previous treatments (refractory) Peripheral T cell Lymphoma, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma.
   
The purpose of this study is to evaluate the safety and effectiveness of an investigational drug soquelitinib versus standard of care treatments. Investigational means that soquelitinib has not been approved by the U.S. Food and Drug Administration (FDA).
   
Soquelitinib is given via a pill twice daily (morning and evening) and belinostat or pralatrexate will be given intravenously (meaning through a needle in the vein directly into the blood).
   
Participation is expected to last up to 4 years.

Key Eligibility: 
  1. Open to men and women above the age of 18 who have been diagnosed with Peripheral T cell Lymphoma (PTCL-NOS), Follicular Helper T-cell Lymphomas (FHTCLs), or Systemic Anaplastic Large-cell Lymphoma.
  2. Participants must not have a myocardial infarction within the last 6 months.

Detailed eligibility will be reviewed when contacting the study team.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Simone Mona Morris
212-746-2651
wem9038@med.cornell.edu

Primary Investigator(s)

Jia Ruan, MD, PhD

Protocol ID(s)

Weill Cornell Medicine IRB #:

2507029073

ClinicalTrials.gov:

NCT06561048

Sponsor:

CPI-818-004

Status

Open to Enrollment

Age Group

Adult

Sponsor

  • Corvus Pharmaceuticals

Disease

Lymphoma
Follicular Lymphoma
T-Cell Lymphoma