Study Comparing Soquelitinib to Standard Treatments for Certain Types of Relapsed or Refractory T-cell Lymphomas

Sponsor: Corvus Pharmaceuticals, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT06561048

Provider View

This clinical trial is testing a new drug, soquelitinib, against standard treatments to see which is more effective for patients with specific types of T-cell lymphomas that have returned or not responded to previous treatments.

Patient Parameters

Program Overview

The study aims to compare the effectiveness of a new drug, soquelitinib, with standard treatments chosen by doctors for patients with certain types of T-cell lymphomas that have come back or are not responding to treatment. The trial will involve about 150 participants who will be randomly assigned to receive either soquelitinib or a standard treatment. Participants will continue treatment for up to two years or until their disease progresses or they experience unacceptable side effects. Those receiving standard treatment may switch to soquelitinib if their disease worsens.

Description

This study is testing a new oral medication called soquelitinib, which targets specific proteins in T-cells, against standard treatments for patients with certain types of T-cell lymphomas that have returned or are not responding to treatment. Participants will be randomly assigned to receive either soquelitinib or a standard treatment, which could be belinostat or pralatrexate. The study will take place in multiple centers and will include patients from different regions, ages, and times since their last treatment. Participants will receive treatment for up to two years or until their disease progresses or they experience unacceptable side effects. If the disease progresses while on standard treatment, participants may have the option to switch to soquelitinib.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older.
  • Good overall health with an ECOG performance status of 0 to 2.
  • Diagnosed with specific types of T-cell lymphomas.
  • Cancer has returned or not responded to at least one but no more than three previous treatments.
  • Cancer can be detected by scans and is at least 1.5 cm in size.
  • Life expectancy of more than 12 weeks.
  • Adequate organ function, including specific blood counts and liver and kidney function.
  • Women of childbearing potential must use effective contraception during and after the study.
  • Men must use condoms and spermicide during and after the study.

Exclusion Criteria

  • T-cell lymphoma that has spread to the brain or spinal cord.
  • Serious medical conditions or psychiatric illnesses that could interfere with the study.
  • Active infections requiring IV treatment.
  • History of other cancers requiring treatment in the last 3 years.
  • Positive for HIV or chronic hepatitis B or C.
  • Recent cancer treatments within a few weeks before starting the study.
  • Previous stem cell transplants or candidates for such transplants.
  • Women who are pregnant, breastfeeding, or planning to become pregnant during the study.

Locations

FACILITYZIPCITYSTATE
Corvus Clinical Trials Information94010BurlingameCalifornia

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