T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)

Launched by ESTRELLA BIOPHARMA, INC. · Mar 26, 2024

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ClinConnect Summary

This clinical trial is studying a new treatment called EB103, which is a type of T-cell therapy designed for adults with relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL). This means it's for patients whose cancer has either come back after treatment or hasn't responded to previous therapies. The trial aims to find out how safe this treatment is and to determine the best dose to use in future studies. If you're at least 18 years old and have been diagnosed with this type of lymphoma after trying multiple treatments, you might be eligible to participate.

Participants in the trial can expect to receive the EB103 treatment, which involves using their own modified T-cells to help fight the cancer. The study is currently recruiting, and it includes a careful process to monitor safety and effectiveness. It's important to know that there are specific criteria for joining, such as having stable organ function and not having certain health issues that could complicate treatment. If you or a loved one is considering this option, it could be a chance to access a new therapy that may help in managing this challenging condition.

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Eligibility criteria

• Inclusion Criteria:
• • Age 18 years or older at the time of informed consent
• • Histologically confirmed R/R B-cell non-Hodgkin's lymphoma (NHL)
• • Adequate organ function
• * Relapsed or refractory (R/R) disease defined as ONE OR MORE of the following:
• • R/R after ≥ 2 lines of systemic therapy
• • For the following NHL types: Burkitt lymphoma, Precursor B-cell lymphoblastic lymphoma, or Mantle cell lymphoma: R/R after ≥ 1 lines of systemic therapy
• • Disease progression or recurrence ≤ 12 months after autologous hematopoietic stem cell transplantation (HSCT)
• • For subjects who are considered transplant-ineligible: progressive disease as best response after ≥ 4 cycles of first-line therapy and stable disease as best response after ≥ 2 cycles of second-line (salvage) therapy; subject must have received an anti-CD20 monoclonal antibody and an anthracycline as one of their qualifying regimens
• * All subjects must have received an appropriate chemoimmunotherapy regimen which at a minimum includes an:
• • Anti-CD20 monoclonal antibody AND
• • An anthracycline-containing chemotherapy regimen
• • Positron emission tomography (PET)-positive disease according to Cheson 2014
• • Eastern Cooperative Oncology Group (ECOG) ≤ 2
• • Toxicities due to prior therapy must be stable and recovered to Grade 1 or less
• Exclusion Criteria:
• • Prior CD19-targeted cellular therapy
• • History of Richter's transformation of chronic lymphocytic leukemia (CLL)
• • History of another primary malignancy that has not been in remission for ≥ 2 years.
• • History or presence of clinically relevant Central Nervous System (CNS) pathology
• • CNS disease which is progressing on most recent therapy or with a parenchymal mass which is likely to cause clinical symptoms
• • Subjects with active cardiac lymphoma involvement which is not responding to treatment
• • History of myocardial infarction, cardiac angioplasty and stenting, unstable angina, or other clinically significant cardiac disease within 6 months of informed consent
• • Active, uncontrolled systemic bacterial, fungal, or viral infection. Patients with HIV, hepatitis B, or hepatitis C are eligible provided their infection is being treated and the viral load is controlled.
• • History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years
• • History of severe, immediate hypersensitivity reaction to any agents used in this study, including the conditioning chemotherapeutic agents
• • Venous thrombosis or embolism not managed on a stable regimen of anticoagulation
• • Autologous HSCT within 3 months of informed consent
• • Subjects with a prior allogeneic transplant at least 6 months prior to study enrollment are eligible unless experienced graft-versus-host disease (GvHD) that requires ongoing treatment with systemic steroids or other systemic GvHD therapy, such as a calcineurin inhibitor, within 12 weeks of initial screening
• • Live vaccine within 3 months prior to planned start of conditioning regimen