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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified March 2026 by Corvus Pharmaceuticals, Inc.
Sponsor
Corvus Pharmaceuticals, Inc.
Information Provided by (Responsible Party)
Corvus Pharmaceuticals, Inc.
Clinicaltrials.gov Identifier
NCT06561048
Other Study ID Numbers:
CPI-818-004
First Submitted
August 15, 2024
First Posted
August 18, 2024
Last Update Posted
April 7, 2026
Last Verified
March 2026

ClinicalTrials.gov processed this data on April 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study 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.

Condition or DiseaseIntervention/Treatment
Peripheral T-Cell Lymphoma, Not Otherwise SpecifiedAngioimmunoblastic T-cell LymphomaFollicular T-Cell LymphomaNodal Peripheral T-Cell Lymphoma With TFH PhenotypeSystemic Anaplastic Large Cell LymphomaLymphoma, T-Cell, PeripheralLymphoma, T-Cell
Drug: SoquelitinibDrug: Belinostat

Study Design

Study TypeInterventional
Actual Enrollment150 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA 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
Study Start DateOctober 1, 2024
Actual Primary Completion Date1yr 5mos from now
Actual Study Completion Date2yrs 6mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
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
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

Outcome Measures

Primary Outcome Measures
  1. Progression-free survival
    Time from first study treatment to first occurrence of progression (as assessed by the Independent Review Committee) or death, whichever occurs first
Secondary Outcome Measures
  1. Objective response rate
    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
  2. Overall survival
    Time from first study treatment to death from any cause

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsCorvus Pharmaceuticals, Inc.
Locations
City of Hope National Medical Center | Duarte California, United States, 91010University of California, Irvine | Irvine California, United States, 92697University of California San Francisco | San Francisco California, United States, 94143Yale University | New Haven Connecticut, United States, 06520Sylvester Comprehensive Cancer Center University of Miami Miller School of Medicine | Miami Florida, United States, 33136Emory University | Atlanta Georgia, United States, 30322North Western University Robert H. Lurie Comprehensive Cancer Center RHLCCC | Chicago Illinois, United States, 60611University of Iowa | Iowa City Iowa, United States, 52242University of Maryland Medical Center | Baltimore Maryland, United States, 21201Massachusetts General Hospital | Boston Massachusetts, United States, 02114Roger Cancer Center University of Michigan Health | Ann Arbor Michigan, United States, 48109Washington University in St. Louis | St Louis Missouri, United States, 63130Hackensack University Medical Center | Hackensack New Jersey, United States, 07601Icahn School of Medicine at Mount Sinai | New York New York, United States, 10029Memorial Sloan Kettering Cancer Center | New York New York, United States, 10065Weill Cornell Medicine | New York New York, United States, 10065North Carolina Cancer Hospital | Chapel Hill North Carolina, United States, 27514The Ohio State University | Columbus Ohio, United States, 43210MD Anderson Cancer Center | Houston Texas, United States, 77030University of Washington Fred Hutch Cancer Center | Seattle Washington, United States, 98109University of Wisconsin Carbone Cancer Center | Madison Wisconsin, United States, 53792St Vincent's Hospital Sydney | Darlinghurst New South Wales, Australia, 2010St George Hospital | Kogarah New South Wales, Australia, 2217ICON Cancer Centre | South Brisbane Queensland, Australia, 4101Royal Adelaide Hospital | Adelaide South Australia, Australia, 5000Flinders Medical Center | Bedford Park South Australia, Australia, 5042Royal Hobart Hospital | Hobart Tasmania, Australia, 7000Box Hill Hospital | Box Hill Victoria, Australia, 3128Austin Hospital | Heidelberg Victoria, Australia, 3084Epworth Healthcare | Richmond Victoria, Australia, 3121Linear Clinical Research | Perth Western Australia, Australia, 6009BC Cancer Research Institute | Vancouver British Columbia, Canada, V5Z4E6The Ottawa Hospital - General Campus | Ottawa Ontario, Canada, K1H8L6The Princess Margaret Cancer Centre | Toronto Ontario, Canada, M5G2C4
Investigators
Study Director: Suresh Mahabhashyam, MD, MPH, Corvus Pharmaceuticals, Inc.