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

NCT06561048 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: CPI-818-004
• Study Type: interventional
• Target: 150
• Locations: 3 countries
• Sites: 34

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

Nodal Peripheral T-Cell Lymphoma With TFH Phenotype; Systemic Anaplastic Large Cell Lymphoma; Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell; Angioimmunoblastic T-cell Lymphoma; Peripheral T-Cell Lymphoma, Not Otherwise Specified; Follicular T-Cell Lymphoma

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)

Outcome Measures

Primary Outcomes (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

  Up to 4 years post study treatment initiation

Secondary Outcomes (2)

• Objective response rate

  Up to 2 years post study treatment initiation

• Overall survival

  Up to 4 years post study treatment initiation

Study Arms (2)

Soquelitinib

EXPERIMENTAL

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

Drug: Soquelitinib

Standard of Care

ACTIVE COMPARATOR

Participants will receive physician's choice standard of care treatment of either pralatrexate or belinostat for up to 2 years

Drug: Belinostat; Drug: Pralatrexate

Interventions

Soquelitinib DRUG

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

Also known as: CPI-818

Soquelitinib

Belinostat DRUG

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

Also known as: Beleodaq®

Standard of Care

Pralatrexate DRUG

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

Also known as: Folotyn®

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Corvus Pharmaceuticals, Inc.: lead

Study Sites (34)

City of Hope National Medical Center

Duarte, California, 91010, United States

RECRUITING

University of California, Irvine

Irvine, California, 92697, United States

RECRUITING

University of California San Francisco

San Francisco, California, 94143, United States

RECRUITING

Yale University

New Haven, Connecticut, 06520, United States

RECRUITING

Sylvester Comprehensive Cancer Center University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

North Western University Robert H. Lurie Comprehensive Cancer Center RHLCCC

Chicago, Illinois, 60611, United States

RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Roger Cancer Center University of Michigan Health

Ann Arbor, Michigan, 48109, United States

RECRUITING

Washington University in St. Louis

St Louis, Missouri, 63130, United States

RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Weill Cornell Medicine

New York, New York, 10065, United States

RECRUITING

North Carolina Cancer Hospital

Chapel Hill, North Carolina, 27514, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

University of Washington Fred Hutch Cancer Center

Seattle, Washington, 98109, United States

RECRUITING

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

RECRUITING

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, 2010, Australia

RECRUITING

St George Hospital

Kogarah, New South Wales, 2217, Australia

RECRUITING

ICON Cancer Centre

South Brisbane, Queensland, 4101, Australia

RECRUITING

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

RECRUITING

Flinders Medical Center

Bedford Park, South Australia, 5042, Australia

RECRUITING

Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia

RECRUITING

Box Hill Hospital

Box Hill, Victoria, 3128, Australia

RECRUITING

Austin Hospital

Heidelberg, Victoria, 3084, Australia

RECRUITING

Epworth Healthcare

Richmond, Victoria, 3121, Australia

RECRUITING

Linear Clinical Research

Perth, Western Australia, 6009, Australia

RECRUITING

BC Cancer Research Institute

Vancouver, British Columbia, V5Z4E6, Canada

RECRUITING

The Ottawa Hospital - General Campus

Ottawa, Ontario, K1H8L6, Canada

RECRUITING

The Princess Margaret Cancer Centre

Toronto, Ontario, M5G2C4, Canada

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell; Immunoblastic Lymphadenopathy; Lymphoma, Large-Cell, Anaplastic; Lymphoma, T-Cell, Peripheral

Interventions

belinostat; 10-propargyl-10-deazaaminopterin

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphadenopathy

Study Officials

• Suresh Mahabhashyam, MD, MPH

  Corvus Pharmaceuticals, Inc.

  STUDY DIRECTOR

Central Study Contacts

Study Director

CONTACT

650-900-4520; clinicaltrials@corvuspharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 19, 2024
• Study Start: October 2, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

US (21); CA (3); AU (10)