Recruiting
Phase 3

Soquelitinib vs. Standard of Care

Sponsor:

Corvus Pharmaceuticals, Inc.

Code:

NCT06561048

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Soquelitinib

Belinostat

Pralatrexate

Study Details

Brief 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 (FHTCLs), or systemic anaplastic large-cell lymphoma (sALCL).

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

Study ID

NCT06561048

Start date

Oct 2, 2024

Status verified date

Apr, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Soquelitinib

Participants will administer soquelitinib 200 mg orally twice daily for up to 2 years

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

Interventions

Soquelitinib

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

Belinostat

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

Pralatrexate

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

Primary outcome measure

  • Progression-free survival [ Time Frame: Up to 4 years post study treatment initiation ]

Central Contacts and Locations

Central contacts

Locations

City of Hope National Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Christina Poh, MD

626-713-7102cpoh@coh.org

Principal Investigator:

Christina Poh, MD

University of California, Irvine

Recruiting

Irvine, California, United States, 92697

Contacts

Research Contact

ucstudy@hs.uci.edu

University of California San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Principal Investigator:

Weiyun Ai, MD

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Principal Investigator:

Francine Foss, MD

Sylvester Comprehensive Cancer Center University of Miami Miller School of Medicine

Recruiting

Miami, Florida, United States, 33136

Contacts

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

North Western University Robert H. Lurie Comprehensive Cancer Center RHLCCC

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Principal Investigator:

Jonathan Moreira, MD

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Principal Investigator:

Eric Mou, MD

University of Maryland Medical Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Principal Investigator:

Kathryn Kline, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Principal Investigator:

Salvia Jain, MD

Roger Cancer Center University of Michigan Health

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Principal Investigator:

Ryan Wilcox, MD

Washington University in St. Louis

Recruiting

St Louis, Missouri, United States, 63130

Contacts

Principal Investigator:

Neha Mehta-Shah, MD

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Principal Investigator:

Tatyana Feldman, MD

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Principal Investigator:

Roshan Asrani, MD

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Dr. Jasmine Zain

zainj1@mskcc.org

Principal Investigator:

Jasmine Zain, MD

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

Principal Investigator:

Jia Ruan, MD, PHD

North Carolina Cancer Hospital

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Cancer Clinical Trials Office

cancerclinicaltrials@med.unc.edu

Principal Investigator:

Anne Beaven, MD

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator:

John Reneau, MD, PHD

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Dr. Swaminathan Iyer, MD

1-877-632-6789SPIyer@mdanderson.org

Principal Investigator:

Swaminathan Iyer, MD

University of Washington Fred Hutch Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

Principal Investigator:

Stephen Smith, MD

University of Wisconsin Carbone Cancer Center

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

BC Cancer Research Institute

Recruiting

Vancouver, British Columbia, Canada, V5Z4E6

The Ottawa Hospital - General Campus

Recruiting

Ottawa, Ontario, Canada, K1H8L6

The Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G2C4

Principal Investigator:

Anca Prica

More Information

Sponsor

Corvus Pharmaceuticals, Inc.

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

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)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Corvus Pharmaceuticals, Inc. on 2026-04-08.