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Tyrosine Kinase Inhibitor

Soquelitinib for Peripheral T-Cell Lymphoma

Phase 3
Recruiting
Research Sponsored by Corvus Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult participants ≥18 years of age on the day of signing the informed consent form
Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease of at least 1.5 cm by computed tomography, as assessed by the site radiologist
Must not have
History of invasive prior malignancy that required systemic therapy within last 3 years
Participants who have T-cell lymphoma with active central nervous system involvement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years post study treatment initiation
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is comparing a new drug called soquelitinib to the standard treatment chosen by the doctor for patients with certain types of relapsed or refractory peripheral T-cell lymphoma.

Who is the study for?
This trial is for adults over 18 with certain types of T-cell lymphoma who have tried up to three treatments that didn't work or they couldn't tolerate. They should be relatively active (able to care for themselves), have a life expectancy over 12 weeks, and their cancer must show on scans.
What is being tested?
The study compares Soquelitinib, a new treatment, against the standard drugs chosen by the doctor (Belinostat or Pralatrexate) in patients with specific T-cell lymphomas. It's an open-label Phase 3 trial where participants are randomly assigned to one of two groups.
What are the potential side effects?
Potential side effects include reactions related to immune system activation, such as fever and fatigue; digestive issues like nausea; blood-related problems including low counts leading to increased infection risk; and possible liver function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years or older.
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My cancer shows up on PET scans and has a tumor at least 1.5 cm big on CT scans.
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I am able to care for myself and perform daily activities.
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My lymphoma type is confirmed as PTCL-NOS, FHTCLs, or sALCL.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I had cancer that needed treatment throughout my body in the last 3 years.
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My T-cell lymphoma affects my brain or spinal cord.
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I have had a stem cell transplant from a donor.
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I am eligible for a stem cell transplant.
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My condition worsened within 6 months after my stem cell transplant.
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I am not pregnant, breastfeeding, nor plan to become pregnant during the study.
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I am currently receiving IV treatment for an infection.
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I haven't had cancer treatments like chemotherapy or targeted therapy in the last 3 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years post study treatment initiation
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years post study treatment initiation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-free survival
Secondary study objectives
Objective response rate
Overall survival

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SoquelitinibExperimental Treatment1 Intervention
Participants will administer soquelitinib 200 mg orally twice daily for up to 2 years
Group II: Standard of CareActive Control2 Interventions
Participants will receive physician's choice standard of care treatment of either pralatrexate or belinostat for up to 2 years

Find a Location

Who is running the clinical trial?

Corvus Pharmaceuticals, Inc.Lead Sponsor
8 Previous Clinical Trials
941 Total Patients Enrolled
Suresh Mahabhashyam, MD, MPHStudy DirectorCorvus Pharmaceuticals, Inc.
1 Previous Clinical Trials
151 Total Patients Enrolled
~100 spots leftby Feb 2026
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