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New pill shows promise in Hard-to-Treat blood cancer

NCT ID NCT06561048

Disease control Sponsor: Corvus Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests a new oral drug, soquelitinib, against standard single-agent chemotherapy in 150 adults with relapsed or refractory peripheral T-cell lymphoma. The study aims to see if soquelitinib can delay cancer progression better than current options. Participants are randomly assigned to receive either soquelitinib or a standard drug chosen by their doctor.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Soquelitinib (an ITK inhibitor taken as a pill)
What this could lead to
If successful, soquelitinib could offer a new, more targeted treatment option for people with certain types of T-cell lymphoma that have not responded to prior therapy.
What could go wrong
This is a phase 3 trial, but it is still experimental. The drug may not prove more effective than existing treatments, and side effects are possible. Results may not apply to all lymphoma subtypes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

anaplastic large cell lymphoma angioimmunoblastic T-cell lymphoma mature T-cell and NK-cell non-Hodgkin lymphoma Nodal T-follicular helper cell lymphoma, follicular type peripheral T-cell lymphoma, not otherwise specified T-cell non-Hodgkin lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Angioimmunoblastic T-cell lymphoma Follicular T-cell lymphoma Lymphoma, T cell, peripheral Lymphoma, T-cell Nodal peripheral T-cell lymphoma with TFH phenotype Peripheral T-cell lymphoma, not otherwise specified Systemic anaplastic large cell lymphoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    34 sites in 3 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Austin Hospital

    RECRUITING

    Heidelberg, Victoria, 3084, Australia

  • BC Cancer Research Institute

    RECRUITING

    Vancouver, British Columbia, V5Z4E6, Canada

  • Box Hill Hospital

    RECRUITING

    Box Hill, Victoria, 3128, Australia

  • City of Hope National Medical Center

    RECRUITING

    Duarte, California, 91010, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Epworth Healthcare

    RECRUITING

    Richmond, Victoria, 3121, Australia

  • Flinders Medical Center

    RECRUITING

    Bedford Park, South Australia, 5042, Australia

  • Hackensack University Medical Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • ICON Cancer Centre

    RECRUITING

    South Brisbane, Queensland, 4101, Australia

    Contact Email: •••••@•••••

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Linear Clinical Research

    RECRUITING

    Perth, Western Australia, 6009, Australia

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • North Carolina Cancer Hospital

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

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

    RECRUITING

    Chicago, Illinois, 60611, United States

    Contact Email: •••••@•••••

  • Roger Cancer Center University of Michigan Health

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Royal Adelaide Hospital

    RECRUITING

    Adelaide, South Australia, 5000, Australia

  • Royal Hobart Hospital

    RECRUITING

    Hobart, Tasmania, 7000, Australia

  • St George Hospital

    RECRUITING

    Kogarah, New South Wales, 2217, Australia

  • St Vincent's Hospital Sydney

    RECRUITING

    Darlinghurst, New South Wales, 2010, Australia

    Contact Email: •••••@•••••

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

    RECRUITING

    Miami, Florida, 33136, United States

  • The Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • The Ottawa Hospital - General Campus

    RECRUITING

    Ottawa, Ontario, K1H8L6, Canada

  • The Princess Margaret Cancer Centre

    RECRUITING

    Toronto, Ontario, M5G2C4, Canada

  • University of California San Francisco

    RECRUITING

    San Francisco, California, 94143, United States

  • University of California, Irvine

    RECRUITING

    Irvine, California, 92697, United States

    Contact Email: •••••@•••••

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Maryland Medical Center

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Washington Fred Hutch Cancer Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • University of Wisconsin Carbone Cancer Center

    RECRUITING

    Madison, Wisconsin, 53792, United States

    Contact Email: •••••@•••••

  • Washington University in St. Louis

    RECRUITING

    St Louis, Missouri, 63130, United States

  • Weill Cornell Medicine

    RECRUITING

    New York, New York, 10065, United States

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06520, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.