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Soquelitinib for Relapsed/Refractory T-cell Lymphoma

This study is testing a new oral medication called soquelitinib for people with certain types of relapsed or refractory (meaning it came back or didn't respond to previous treatment) peripheral T-cell lymphoma (a type of blood cancer). This includes Peripheral T-Cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma. Soquelitinib is being compared to standard treatments like belinostat or pralatrexate. The main goal is to see if soquelitinib can help people live longer without their cancer getting worse. You may be able to join if you are 18 or older and have one of these specific lymphoma types. The study is currently recruiting about 150 participants.

Study design
This is a Phase 3, randomized study involving about 150 participants. You would be randomly assigned to receive either soquelitinib or a standard treatment, and both you and your doctor would know which treatment you are receiving.
What's involved
You would receive study treatment for up to 2 years, or until your cancer progresses or side effects become too severe. If you are in the standard treatment group and your cancer progresses, you might have the option to switch to soquelitinib.
Compensation
Not stated in the trial record.
Follow-up
Your health will be monitored for up to 4 years after you start treatment to see how long you live without your cancer progressing.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06561048

Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma

Recruiting
PHASE3Ages 18+InterventionalTreatment
Corvus Pharmaceuticals, Inc.
~150 participants
Updated 2026-04-08 on ClinicalTrials.gov
What's tested:SoquelitinibBelinostatPralatrexate

At a glance

Recruiting sites
34 of 34 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival
Measured over Up to 4 years post study treatment initiation

Conditions

Peripheral T-Cell Lymphoma, Not Otherwise Specified
Angioimmunoblastic T-cell Lymphoma
Follicular T-Cell Lymphoma
Nodal Peripheral T-Cell Lymphoma With TFH Phenotype
Systemic Anaplastic Large Cell Lymphoma
Lymphoma, T-Cell, Peripheral
Lymphoma, T-Cell

Explore related trials

Follicular Helper T-Cell LymphomaPeripheral T-Cell Lymphoma, Not Otherwise SpecifiedSystemic Anaplastic Large Cell Lymphoma

NCT06561048

Where you'd take part

This study runs at 34 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Austin Hospital

    Heidelberg, Victoria, Australiastudy coordinator listed

    Recruiting

  • Box Hill Hospital

    Box Hill, Victoria, Australiastudy coordinator listed

    Recruiting

  • City of Hope National Medical Center

    Duarte, Californiastudy coordinator listed

    Recruiting

  • Emory University

    Atlanta, Georgiastudy coordinator listed

    Recruiting

  • Epworth Healthcare

    Richmond, Victoria, Australiastudy coordinator listed

    Recruiting

  • Flinders Medical Center

    Bedford Park, South Australia, Australiastudy coordinator listed

    Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jerseystudy coordinator listed

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Suresh Mahabhashyam, MD, MPH · STUDY_DIRECTOR · Corvus Pharmaceuticals, Inc.

Who to contact

Study Director
[email protected]
650-900-4520
Email the study team

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Eligibility criteria

Inclusion

Absolute neutrophil count ≥ 1.0×10\^9/L (1000/mm3) (without receiving granulocyte-colony stimulating factor)
Platelet count ≥ 100×10\^9/L (without transfusion)
Hemoglobin ≥ 9.0 g/dL, without packed red blood cell transfusion within the last 1 week of starting study drug
Prothrombin time international normalized ratio and partial thromboplastin time ≤1.5 × upper limit of normal (ULN), unless participant is receiving anticoagulant therapy and prothrombin time or activated partial thromboplastin time is within therapeutic range of intended use of anticoagulants
Calculated creatinine clearance (CrCl) according to Cockcroft-Gault formula and based on ideal body weight or 24-hour urine CrCl ≥ 50 mL/minute
Total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN for participants with total bilirubin levels \> 1.5 × ULN. For participants with Gilbert's disease: ≤ 3.0 mg/dL or discussion with the Medical Monitor
Aspartate aminotransferase and alanine transaminase ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases)
Serum albumin \> 2.5 g/dL
Serum calcium \< 12 mg/dL or corrected serum calcium \< ULN 8. Must have recovered from all AEs due to previous therapies to Grade ≤ 1 or baseline except for the following:
Grade ≤ 2 neuropathy
Alopecia and non-acute toxicities
If major received major surgery, then must have recovered adequately per the investigator from the toxicity and/or complications from the intervention prior to starting study treatment 9. Female participants of childbearing potential who are sexually active with a non-sterilized male partner must agree to use at least 1 highly effective method of contraception from the time of screening and must agree to continue using such precautions for 120 days after the last dose of study drug for participants who receive soquelitinib, or 6 months after the last dose for participants who receive either belinostat or pralatrexate. 10. Non-sterilized males who are sexually active with a female partner of childbearing potential must use a condom plus spermicide from Day 1 through 120 days after the last dose of study drug.

What this trial measures

  • Progression-free survivalUp to 4 years post study treatment initiation

    Time from first study treatment to first occurrence of progression (as assessed by the Independent Review Committee) or death, whichever occurs first