Study on ONCT-808 for Patients with Difficult or Returning B-Cell Blood Cancers

Sponsor: Oncternal Therapeutics, Inc

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05588440

Provider View

This clinical trial is testing a new CAR-T cell therapy called ONCT-808 to see if it is safe and effective for patients with aggressive B-cell blood cancers that have not responded to previous treatments or have returned.

Patient Parameters

Program Overview

This study is exploring a new treatment called ONCT-808, a type of CAR-T cell therapy, for patients with aggressive B-cell blood cancers that have come back or haven't responded to other treatments. The study is divided into two phases. Phase 1 will focus on finding a safe dose, and Phase 2 will test this dose further to see how well it works and how safe it is for patients with large B-cell lymphoma (LBCL) and mantle cell lymphoma (MCL).

Description

The study is designed to evaluate the safety and effectiveness of ONCT-808, a CAR-T cell therapy, in patients with aggressive B-cell lymphomas, including large B-cell lymphoma (LBCL) and mantle cell lymphoma (MCL). It will take place in multiple centers and is divided into two phases.

In Phase 1, researchers will determine the safest dose of ONCT-808. Once this is established, Phase 2 will begin, where the selected dose will be tested further to confirm its safety and effectiveness. Patients with LBCL or MCL will be enrolled in two separate groups to receive the treatment. The study aims to provide new treatment options for patients whose cancer has returned or not responded to previous therapies.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of aggressive B-cell non-Hodgkin lymphoma (NHL), such as:
    • Mantle cell lymphoma (MCL) confirmed by specific tests.
    • Large B-cell lymphoma (LBCL), including various subtypes like diffuse large B-cell lymphoma (DLBCL) and others.
  • Must have tissue samples available for testing or be willing to undergo a biopsy.
  • Cancer must have returned or not responded to previous treatments, including:
    • Prior therapy with specific drugs and treatments.
    • Progression after stem cell transplant or ineligibility/refusal for transplant.
    • Previous CD19 CAR-T therapy or ineligibility/refusal for it.
  • Must have a break between previous treatments and the start of this study, including:
    • At least 14 days after chemotherapy.
    • At least 3 months after stem cell transplant.
    • At least 6 months after CD19 CAR-T therapy.
  • Must have at least one measurable tumor.
  • Must have disease that shows up on specific scans.
  • Must be in good overall health with a performance status of 0 or 1.
  • Must have adequate organ function, including:
    • Specific blood cell counts and organ function tests.
    • Heart function and oxygen levels.
  • Must have an estimated life expectancy of more than 12 weeks.

Exclusion Criteria

  • Previous treatment targeting ROR1.
  • Current or planned use of certain immune-suppressing medications.
  • Inability to pause blood-thinning medications as required.
  • Cancer spread to the brain within the last 6 months.
  • History of or current brain disorders within the last 6 months.
  • Significant heart disease or serious heart rhythm issues within the last year.
  • Evidence of HIV or active hepatitis B or C infections.
  • Recent serious fungal infections.
  • History of COVID-19 with ongoing lung issues.
  • History of other cancers not in remission for at least 2 years, except certain skin cancers.
  • History of autoimmune diseases affecting organs or requiring treatment in the last 2 years.
  • History of stem cell or organ transplant.

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