Study on T-Cell Therapy (EB103) for Adults with Difficult or Returning B-Cell Non-Hodgkin's Lymphoma

Sponsor: Estrella Biopharma, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06343311

Provider View

This clinical trial is testing a new T-cell therapy called EB103 to see if it is safe and to find the best dose for treating adults with B-cell Non-Hodgkin's Lymphoma that has not responded to previous treatments or has come back.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety of a new T-cell therapy, EB103, and to determine the best dose for future studies in adults aged 18 and older with B-cell Non-Hodgkin's Lymphoma (NHL) that has returned or not responded to treatment. The study will start with a phase to find the right dose, followed by a phase to confirm its safety and see how well it works.

Description

This clinical trial is designed to test the safety and determine the best dose of a new T-cell therapy called EB103 for adults with B-cell Non-Hodgkin's Lymphoma (NHL) that has either returned after treatment or has not responded to previous treatments. The study is open-label, meaning both the researchers and participants know what treatment is being given. It will take place in multiple centers and is divided into two phases: a dose escalation phase to find the right dose, and an expansion phase to further test the safety and effectiveness of EB103 at that dose. Participants will receive the therapy and be monitored for any side effects and how well the treatment works.

Eligibility Criteria

Inclusion Criteria

  • Be 18 years or older.
  • Have a confirmed diagnosis of relapsed or refractory B-cell Non-Hodgkin's Lymphoma (NHL).
  • Have adequate organ function.
  • Have disease that has returned or not responded after:
    • At least 2 lines of systemic therapy for most types of NHL.
    • At least 1 line of systemic therapy for Burkitt lymphoma, Precursor B-cell lymphoblastic lymphoma, or Mantle cell lymphoma.
    • Disease progression or return within 12 months after a stem cell transplant.
    • For those not eligible for transplant: progressive disease after at least 4 cycles of first-line therapy and stable disease after at least 2 cycles of second-line therapy, having received an anti-CD20 antibody and an anthracycline.
  • Have received a chemoimmunotherapy regimen including an anti-CD20 antibody and an anthracycline.
  • Have PET-positive disease.
  • Have an ECOG performance status of 2 or less.
  • Have stable and recovered side effects from previous treatments to Grade 1 or less.

Exclusion Criteria

  • Have had prior CD19-targeted cellular therapy.
  • Have a history of Richter's transformation of chronic lymphocytic leukemia (CLL).
  • Have another primary cancer that has not been in remission for at least 2 years.
  • Have significant central nervous system (CNS) issues.
  • Have CNS disease that is worsening or has a mass likely to cause symptoms.
  • Have active cardiac lymphoma not responding to treatment.
  • Have had a heart attack, angioplasty, stenting, or significant heart disease within 6 months.
  • Have an uncontrolled infection. Patients with HIV, hepatitis B, or C are eligible if treated and controlled.
  • Have a history of autoimmune disease needing systemic treatment in the last 2 years.
  • Have severe allergic reactions to study agents.
  • Have unmanaged blood clots.
  • Have had a stem cell transplant within 3 months.
  • Have had an allogeneic transplant at least 6 months ago unless ongoing treatment for graft-versus-host disease is needed.
  • Have received a live vaccine within 3 months before starting the study.

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