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Peripheral T-Cell Lymphoma, Not Otherwise SpecifiedPhase 3NCT06561048

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

A Phase 3 study testing Soquelitinib, Belinostat and Pralatrexate in people with Peripheral T-Cell Lymphoma, Not Otherwise Specified and Angioimmunoblastic T-cell Lymphoma, run by Corvus Pharmaceuticals, Inc. at 37 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Soquelitinib, Belinostat and Pralatrexate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
37 sitesin 3 countries
Study dates
2 Oct 2024to Dec 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult participants ≥18 years of age on the day of signing the informed consent form.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
  • Histologically confirmed PTCL-NOS, FHTCLs or sALCL per The International Consensus Classification of Mature Lymphoid Neoplasms.
  • 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.
  • 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.
  • Life expectancy >12 weeks.
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  • 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
  • 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
  • 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.
  • 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.

Who cannot join

  • Participants who have T-cell lymphoma with active central nervous system involvement.
  • Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
  • History of primary immunodeficiency or sold organ transplantation.
  • History of opportunistic infection within 30days of screening requiring active systemic treatment or active infection requiring IV therapy.
  • Any active infection requiring IV therapy.
  • History of invasive prior malignancy that required systemic therapy within last 3 years.
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  • Any condition that confounds the ability to interpret data from the study.
  • 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.
  • 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.
  • Prior administration of an ITK inhibitor.
  • Participants who need immediate cytoreductive therapy.
  • 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.
  • History of allogeneic hematopoietic stem cell transplantation.
  • Candidate for hematopoietic stem cell transplantation at screening.
  • History of progressive disease within 6 months of autologous hematopoietic stem cell transplantation.
  • Concurrent enrollment in another clinical study
  • 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.
  • Participants who cannot ingest medications orally or who have malabsorption.

Trial locations and contacts

37 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Study Director contact

650-900-4520

clinicaltrials@corvuspharma.com

37 sites in 3 countries

United States24 sites, 24 recruiting

  • Roger Cancer Center University of Michigan Health

    Ann Arbor, Michigan, 48109

    Cancer Answer Line, 1-800-865-1125, CancerAnswerLine@med.umich.edu

    Ryan Wilcox, MD

    Recruiting

  • Emory University

    Atlanta, Georgia, 30322

    Blair Dykeman, 404-778-8641, blair.dykeman@emory.edu

    Recruiting

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

    Hongxia Li, 410-328-7996, Hongxia.Li@umm.edu

    Kathryn Kline, MD

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Dr. Salvia Jain, MD, 617-724-4000, salvia.jain@mgh.harvard.edu

    Salvia Jain, MD

    Recruiting

  • North Carolina Cancer Hospital

    Chapel Hill, North Carolina, 27514

    Cancer Clinical Trials Office, cancerclinicaltrials@med.unc.edu

    Anne Beaven, MD

    Recruiting

  • North Western University Robert H. Lurie Comprehensive Cancer Center RHLCCC

    Chicago, Illinois, 60611

    clinicaltrials@northwestern.edu

    Jonathan Moreira, MD

    Recruiting

  • The Ohio State University

    Columbus, Ohio, 43210

    Madeline Gaines, 614-688-8894, Madeline.Gaines@osumc.edu

    John Reneau, MD, PHD

    Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas, 75235

    Silviya Meletath, 909-560-9597, Silviya.Meletath@UTSouthwestern.edu

    Dr. Elif Yilmaz, MD

    Recruiting

  • City of Hope National Medical Center

    Duarte, California, 91010

    Christina Poh, MD, 626-713-7102, cpoh@coh.org

    Christina Poh, MD

    Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Elizabeth McCarthy, (412) 860-6447, elizabethl.mccarthy@hmhn.org

    Tatyana Feldman, MD

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Dr. Swaminathan Iyer, MD, 1-877-632-6789, SPIyer@mdanderson.org

    Swaminathan Iyer, MD

    Recruiting

  • University of Iowa

    Iowa City, Iowa, 52242

    Dr. Eric Mou, MD, 319-356-1616, eric-mou@uiowa.edu

    Eric Mou, MD

    Recruiting

  • University of California, Irvine

    Irvine, California, 92697

    Research Contact, ucstudy@hs.uci.edu

    Recruiting

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53792

    Cancer Connect, 800-622-8922, clinicaltrials@cancer.wisc.edu

    Recruiting

  • Sylvester Comprehensive Cancer Center University of Miami Miller School of Medicine

    Miami, Florida, 33136

    305-242-5302

    Recruiting

  • Yale University

    New Haven, Connecticut, 06520

    Daniel Moncayo, 203-500-0834, daniel.moncayo@yale.edu

    Francine Foss, MD

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

    Patricia Worker, (212) 824-7337 (x57337), patricia.worker@mssm.edu

    Roshan Asrani, MD

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Dr. Jasmine Zain, zainj1@mskcc.org

    Jasmine Zain, MD

    Recruiting

  • Weill Cornell Medicine

    New York, New York, 10065

    Tejasvi Sahni, tks4001@med.cornell.edu

    Jia Ruan, MD, PHD

    Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

    David Liotta, 412-864-3681, liottada3@upmc.edu

    Dr. Oleg Akilov, MD, PHD

    Recruiting

  • Oregon Health & Science University; Knight Cancer Institute

    Portland, Oregon, 97239

    Clinical Trials Office, 503-494-1080, trials@ohsu.edu

    Dr. Craig Okada, MD

    Recruiting

  • University of California San Francisco

    San Francisco, California, 94143

    Lena Truong, Lena.Truong3@ucsf.edu

    Weiyun Ai, MD

    Recruiting

  • University of Washington Fred Hutch Cancer Center

    Seattle, Washington, 98109

    Research Contact, UWHemMalResearch@fredhutch.org

    Stephen Smith, MD

    Recruiting

  • Washington University in St. Louis

    St Louis, Missouri, 63130

    Anne Fischer, 314-581-0588, afischer@wustl.edu

    Neha Mehta-Shah, MD

    Recruiting

Other trials in United States

Australia10 sites, 10 recruiting

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

    Chris Hoare, Christine.hoare@sa.gov.au

    Pratyush Giri

    Recruiting

  • Flinders Medical Center

    Bedford Park, South Australia, 5042

    Min Kim, Min.kim2@sa.gov.au

    Kate Manos

    Recruiting

  • Box Hill Hospital

    Box Hill, Victoria, 3128

    Liz Arnold, liz.arnold@monash.edu

    Tamara Marconi

    Recruiting

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010

    Joshua Neish, haemclinicaltrialsunit@svha.org.au

    Dr. Orly Lavee, orly.lavee@svha.org.au

    Recruiting

  • Austin Hospital

    Heidelberg, Victoria, 3084

    Samantha Chakar, +61 3 94963088, samantha.chakar@austin.org.au

    Eliza Hawkes

    Recruiting

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

    Holly Price, holly.price@ths.tas.gov.au

    Anna Johnston

    Recruiting

  • St George Hospital

    Kogarah, New South Wales, 2217

    seslhd-stghaematologyclinicaltrials@health.nsw.gov.au

    Recruiting

  • Linear Clinical Research

    Perth, Western Australia, 6009

    Dr. Dejan Radeski, MBBS, Enquiries@linear.org.au

    cancertrialshaem4@linear.org.au

    Recruiting

  • Epworth Healthcare

    Richmond, Victoria, 3121

    Dr. Connie Barlas, Connie.barlas@epworth.org.au

    Recruiting

  • ICON Cancer Centre

    South Brisbane, Queensland, 4101

    Researchsouthbrisbane@icon.team

    Recruiting

Other trials in Australia

Canada3 sites, 3 recruiting

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario, K1H8L6

    Recruiting

  • The Princess Margaret Cancer Centre

    Toronto, Ontario, M5G2C4

    Anca Prica

    Recruiting

  • BC Cancer Research Institute

    Vancouver, British Columbia, V5Z4E6

    Recruiting

Other trials in Canada

About this study

Official title: 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).

Read the 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.

Being tested
Soquelitinib, Belinostat, Pralatrexate
Keywords
Peripheral T-Cell Lymphoma, Not Otherwise Specified (PTCL-NOS), Follicular Helper T-Cell Lymphoma (FHTCL), Angioimmunoblastic T-cell Lymphoma (AITL), Follicular T-Cell Lymphoma (FTCL), Nodal Peripheral T-Cell Lymphoma with T Follicular Helper Phenotype (PTCL-Tfh), Systemic Anaplastic Large Cell Lymphoma (sALCL)
Medical subject headings
Lymphoma, T-Cell, Immunoblastic Lymphadenopathy, Lymphoma, Large-Cell, Anaplastic, Lymphoma, T-Cell, Peripheral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SoquelitinibDrug

    Also called CPI-818

    Soquelitinib 200 mg tablets will be taken by mouth two times a day

  • BelinostatDrug

    Also called Beleodaq®

    Belinostat (1000 mg/m2) will be administered by intravenous infusion once daily on Days 1 through 5 of each 21-day cycle

  • PralatrexateDrug

    Also called Folotyn®

    Pralatrexate (30 mg/m2) will be administered intravenously over 3 to 5 minutes once weekly for 6 weeks in each 7-week cycle

Study groups in NCT06561048
Study groupRoleWhat they receive
SoquelitinibExperimentalParticipants will administer soquelitinib 200 mg orally twice daily for up to 2 years
Receives: Drug: Soquelitinib
Standard of CareActive comparatorParticipants will receive physician's choice standard of care treatment of either pralatrexate or belinostat for up to 2 years
Receives: Drug: Belinostat; Drug: Pralatrexate

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Up to 4 years post study treatment initiation

Secondary outcomes (2)

  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

    Measured: Up to 2 years post study treatment initiation

  2. Overall survival

    Time from first study treatment to death from any cause

    Measured: Up to 4 years post study treatment initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2024
  2. Study start2 Oct 2024
  3. Primary completionNov 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06561048
Sponsor's protocol ID
CPI-818-004
Status last verified
Apr 2026
First submitted
16 Aug 2024
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Soquelitinib, Belinostat and Pralatrexate in people with Peripheral T-Cell Lymphoma, Not Otherwise Specified and Angioimmunoblastic T-cell Lymphoma, run by Corvus Pharmaceuticals, Inc. at 37 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Director (650-900-4520, clinicaltrials@corvuspharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: Up to 4 years post study treatment initiation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06561048.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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