NCT06561048 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
| NCT ID | NCT06561048 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Corvus Pharmaceuticals, Inc. |
| Condition | Peripheral T-Cell Lymphoma, Not Otherwise Specified |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-10-02 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 150 participants in total. It began in 2024-10-02 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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.
Contact & Investigator
Suresh Mahabhashyam, MD, MPH
STUDY DIRECTOR
Corvus Pharmaceuticals, Inc.
Frequently Asked Questions
Who can join the NCT06561048 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peripheral T-Cell Lymphoma, Not Otherwise Specified. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06561048 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 150 participants.
Is NCT06561048 currently recruiting?
Yes, NCT06561048 is actively recruiting participants. Contact the research team at clinicaltrials@corvuspharma.com for enrollment information.
Where is the NCT06561048 trial being conducted?
This trial is being conducted at Duarte, United States, Irvine, United States, San Francisco, United States, New Haven, United States and 11 additional locations.
Who is sponsoring the NCT06561048 clinical trial?
NCT06561048 is sponsored by Corvus Pharmaceuticals, Inc.. The principal investigator is Suresh Mahabhashyam, MD, MPH at Corvus Pharmaceuticals, Inc.. The trial plans to enroll 150 participants.