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

April 2, 2026 updated by: Corvus Pharmaceuticals, Inc.

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 Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma

A Phase 3, randomized, 2-arm, open-label, multicenter, stratified study of soquelitinib versus physician's choice standard of care (SOC) treatment (selected single agents) in participants with relapsed/refractory (R/R) peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), follicular helper T-cell lymphomas (FHTCLs), or systemic anaplastic large-cell lymphoma (sALCL).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 3, randomized, 2-arm, open-label, multicenter, stratified study of soquelitinib, an oral interleukin-2-inducible T cell kinase (ITK) inhibitor, versus physician's choice standard of care (SOC) treatment of either belinostat or pralatrexate in participants with relapsed/refractory (R/R) peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), follicular helper T-cell lymphomas (FHTCLs), or systemic anaplastic large-cell lymphoma (sALCL). Approximately 150 participants will be randomized at a 1:1 ratio to the 2 treatment arms (soquelitinib or SOC) and will be stratified by region of the world, age, and time to relapse for the most recent prior therapy. Participants will receive study treatment for up to a maximum of 2 years, unacceptable toxicity, or disease progression, whichever is earlier. Participants randomized to receive SOC who have confirmation of progressive disease may have the opportunity to crossover to receive treatment with soquelitinib.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
    • Queensland
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Royal Adelaide Hospital
        • Principal Investigator:
          • Pratyush Giri
        • Contact:
      • Bedford Park, South Australia, Australia, 5042
        • Recruiting
        • Flinders Medical Center
        • Principal Investigator:
          • Kate Manos
        • Contact:
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Recruiting
        • Box Hill Hospital
        • Contact:
        • Principal Investigator:
          • Tamara Marconi
      • Heidelberg, Victoria, Australia, 3084
        • Recruiting
        • Austin Hospital
        • Contact:
        • Principal Investigator:
          • Eliza Hawkes
      • Richmond, Victoria, Australia, 3121
    • Western Australia
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z4E6
        • Recruiting
        • BC Cancer Research Institute
    • Ontario
      • Ottawa, Ontario, Canada, K1H8L6
        • Recruiting
        • The Ottawa Hospital - General Campus
      • Toronto, Ontario, Canada, M5G2C4
        • Recruiting
        • The Princess Margaret Cancer Centre
        • Principal Investigator:
          • Anca Prica
  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope National Medical Center
        • Principal Investigator:
          • Christina Poh, MD
        • Contact:
          • Christina Poh, MD
          • Phone Number: 626-713-7102
          • Email: cpoh@coh.org
      • Irvine, California, United States, 92697
        • Recruiting
        • University of California, Irvine
        • Contact:
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California San Francisco
        • Contact:
        • Principal Investigator:
          • Weiyun Ai, MD
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale University
        • Contact:
        • Principal Investigator:
          • Francine Foss, MD
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • Sylvester Comprehensive Cancer Center University of Miami Miller School of Medicine
        • Contact:
          • Phone Number: 305-242-5302
    • Georgia
      • Atlanta, Georgia, United States, 30322
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • North Western University Robert H. Lurie Comprehensive Cancer Center RHLCCC
        • Principal Investigator:
          • Jonathan Moreira, MD
        • Contact:
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa
        • Principal Investigator:
          • Eric Mou, MD
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland Medical Center
        • Contact:
        • Principal Investigator:
          • Kathryn Kline, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • Salvia Jain, MD
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • Roger Cancer Center University of Michigan Health
        • Principal Investigator:
          • Ryan Wilcox, MD
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63130
        • Recruiting
        • Washington University in St. Louis
        • Principal Investigator:
          • Neha Mehta-Shah, MD
        • Contact:
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack University Medical Center
        • Principal Investigator:
          • Tatyana Feldman, MD
        • Contact:
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Weill Cornell Medicine
        • Contact:
        • Principal Investigator:
          • Jia Ruan, MD, PHD
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Principal Investigator:
          • Jasmine Zain, MD
        • Contact:
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School Of Medicine At Mount Sinai
        • Principal Investigator:
          • Roshan Asrani, MD
        • Contact:
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • North Carolina Cancer Hospital
        • Principal Investigator:
          • Anne Beaven, MD
        • Contact:
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University
        • Contact:
        • Principal Investigator:
          • John Reneau, MD, PHD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Principal Investigator:
          • Swaminathan Iyer, MD
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • University of Washington Fred Hutch Cancer Center
        • Principal Investigator:
          • Stephen Smith, MD
        • Contact:
    • Wisconsin
      • Madison, Wisconsin, United States, 53792

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adult participants ≥18 years of age on the day of signing the informed consent form.
  2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
  3. Histologically confirmed PTCL-NOS, FHTCLs or sALCL per The International Consensus Classification of Mature Lymphoid Neoplasms.
  4. Progressed on, be refractory to, relapsed, or intolerant to standard therapy for their cancer. At least 1 but not more than 3 prior systemic therapies.
  5. 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.
  6. Life expectancy >12 weeks.

  7. Adequate organ function as determined by:

    • 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.

Exclusion Criteria:

  1. Participants who have T-cell lymphoma with active central nervous system involvement.
  2. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
  3. History of primary immunodeficiency or sold organ transplantation.
  4. History of opportunistic infection within 30days of screening requiring active systemic treatment or active infection requiring IV therapy.
  5. Any active infection requiring IV therapy.
  6. History of invasive prior malignancy that required systemic therapy within last 3 years.
  7. Any condition that confounds the ability to interpret data from the study.
  8. Known to be positive for HIV, or positive test for chronic hepatitis B virus (HBV) infection (defined as positive hepatitis B surface antigen [HBsAg]) or positive test for hepatitis C antibody.
  9. Monoclonal antibody therapy for cancer, radiotherapy, or chemotherapy within 3 weeks and targeted therapy within 2 weeks prior to the first dose of study treatment.
  10. Prior administration of an ITK inhibitor.
  11. Participants who need immediate cytoreductive therapy.
  12. Participants requiring the concomitant use of strong inhibitors or inducers of CYP3A or who have received these within 5 half-lives or 14 days prior to the start of study treatment.
  13. History of allogeneic hematopoietic stem cell transplantation.
  14. Candidate for hematopoietic stem cell transplantation at screening.
  15. History of progressive disease within 6 months of autologous hematopoietic stem cell transplantation.
  16. Concurrent enrollment in another clinical study
  17. Females who are pregnant, lactating, or intend to become pregnant during their participation in the study, starting with the screening visit through 6 months after the last dose of study treatment.
  18. Participants who cannot ingest medications orally or who have malabsorption.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Soquelitinib
Participants will administer soquelitinib 200 mg orally twice daily for up to 2 years
Drug: Soquelitinib
Soquelitinib 200 mg tablets will be taken by mouth two times a day
Other Names:
  • CPI-818
Active Comparator: Standard of Care
Participants will receive physician's choice standard of care treatment of either pralatrexate or belinostat for up to 2 years
Drug: Belinostat
Belinostat (1000 mg/m2) will be administered by intravenous infusion once daily on Days 1 through 5 of each 21-day cycle
Other Names:
  • Beleodaq®
Drug: Pralatrexate
Pralatrexate (30 mg/m2) will be administered intravenously over 3 to 5 minutes once weekly for 6 weeks in each 7-week cycle
Other Names:
  • Folotyn®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: Up 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
Up to 4 years post study treatment initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: Up to 2 years post study treatment initiation
The rate of participants who achieve a partial response or complete response as assessed by the Independent Review Committee according to the Revised Criteria for Response Assessment of Malignant Lymphoma (Lugano Classification 2014), and modified Severity Weighted Assessment Tool (mSWAT) for participants with skin involvement
Up to 2 years post study treatment initiation
Overall survival
Time Frame: Up to 4 years post study treatment initiation
Time from first study treatment to death from any cause
Up to 4 years post study treatment initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corvus Pharmaceuticals, Inc.

Investigators

  • Study Director: Suresh Mahabhashyam, MD, MPH, Corvus Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2024

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

August 16, 2024

First Submitted That Met QC Criteria

August 16, 2024

First Posted (Actual)

August 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPI-818-004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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