First-in-Human Trial of 1A46 for Advanced CD20 and/or CD19 Positive B-cell Blood Cancers

Sponsor: Chimagen Biosciences, Ltd

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05348889

Provider View

This clinical trial is testing a new treatment called 1A46 to see if it is safe and effective for adults with advanced B-cell blood cancers that are positive for CD20 and/or CD19 markers, such as certain types of non-Hodgkin's lymphoma and acute lymphoblastic leukemia.

Patient Parameters

Program Overview

The study aims to evaluate the safety and effectiveness of a new drug, 1A46, in adults with advanced B-cell blood cancers that have specific markers (CD20 and/or CD19). These include certain types of non-Hodgkin's lymphoma (NHL) and acute lymphoblastic leukemia (ALL) that have not responded to standard treatments. The trial will be conducted in two parts: the first part will determine the best dose, and the second part will expand the study to more patients to further assess the treatment's effects.

Description

This study is designed to test a new drug, 1A46, in adults with advanced B-cell blood cancers that have not responded to other treatments. The trial will be conducted in two parts. The first part will focus on finding the right dose of 1A46, while the second part will involve more patients to see how well the treatment works. Participants will be divided into four groups based on their specific type of cancer and previous treatments. The study will take place at multiple centers and is open-label, meaning both the researchers and participants will know what treatment is being given.

Eligibility Criteria

Inclusion Criteria

  • For Aggressive NHL Patients:

    • Have aggressive types of NHL, such as mantle cell lymphoma or diffuse large B-cell lymphoma (DLBCL).
    • Have had at least two previous treatments, including therapies like R-CHOP or R-EPOCH.
    • Have tried or are not eligible for a stem cell transplant.
    • Have tried all other standard treatments that might help.

  • For Indolent NHL Patients:

    • Have types of NHL like follicular lymphoma or marginal zone lymphoma.
    • Have had at least two previous treatments and need more treatment based on their disease.

  • For ALL Patients:

    • Have B-cell ALL that has not responded to initial treatment and one additional treatment.
    • Have tried all other standard treatments that might help.
    • Have no active graft-versus-host disease and are not on immunosuppressive therapy.

  • All Patients:

    • Must have CD20 and/or CD19 markers on their cancer cells.
    • Must have at least one measurable tumor or cancer site.
    • Must meet specific health criteria and have no effective standard treatment options available.

Exclusion Criteria

  • Have brain metastasis or serious neurological conditions.
  • Are pregnant or breastfeeding.
  • Have a serious infection requiring antibiotics within 14 days before the study.
  • Are taking high doses of steroids or immunosuppressive medications, with some exceptions.
  • Have active hepatitis B or C, or HIV.
  • Have a history of drug or alcohol abuse.
  • Have had recent heart problems or major surgery.
  • Have received live vaccines within 30 days before the study.
  • Have certain chronic inflammatory diseases.
  • Have had severe allergic reactions to similar treatments.
  • Have an active COVID-19 infection.
  • Have another cancer within the last 5 years, except for certain types.
  • Have had severe immune-related side effects from previous treatments.
  • Have fluid buildup around the lungs, heart, or abdomen requiring frequent treatment.
  • Have a specific heart condition (QTc > 480 msec).
  • Weigh less than 40 kg if participating in the dose escalation part.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.