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Englumafusp Alfa

Englumafusp alfa, a novel drug targeting CD19, is currently being studied in clinical trials for the treatment of relapsed or refractory Non-Hodgkin’s Lymphoma (NHL). This article provides an overview of the ongoing research, focusing on its combination with other drugs and its potential impact on patients with this challenging condition.

Table of Contents

What is Englumafusp Alfa?

Englumafusp alfa, also known as RO7227166 or A CD19 Targeted 4-1BB Ligand, is a new drug being studied for the treatment of Non-Hodgkin’s Lymphoma (NHL)[1]. This medication is currently undergoing clinical trials to evaluate its safety and effectiveness in patients with relapsed or refractory (r/r) NHL, which means their cancer has either returned after initial treatment or did not respond well to previous therapies.

Target Condition: Non-Hodgkin’s Lymphoma

Non-Hodgkin’s Lymphoma is a type of cancer that affects the lymphatic system, which is part of the body’s immune system. It occurs when white blood cells called lymphocytes grow abnormally and can form tumors throughout the body[1]. The clinical trial for englumafusp alfa focuses on patients with various subtypes of NHL, including:

  • Diffuse Large B-cell Lymphoma (DLBCL): A fast-growing type of NHL that affects B-lymphocytes
  • High-grade B-cell Lymphoma (HGBCL): An aggressive form of NHL
  • Primary Mediastinal B-cell Lymphoma (PMBCL): A rare type of NHL that develops in the chest area
  • Transformed Follicular Lymphoma: When a slow-growing lymphoma changes into a more aggressive form

How Englumafusp Alfa Works

Englumafusp alfa is designed to target CD19, a protein found on the surface of B-cells, including cancerous B-cells in NHL[1]. It also interacts with the 4-1BB receptor, which is involved in stimulating the immune system. By combining these two targets, englumafusp alfa aims to enhance the body’s immune response against lymphoma cells while specifically targeting the cancer.

Clinical Trial Overview

The clinical trial for englumafusp alfa is a Phase I/II study, which means it is in the early stages of testing in humans[1]. The study is divided into three parts:

  1. Part I: Dose-escalation stage combining englumafusp alfa with obinutuzumab
  2. Part II: Dose-escalation stage combining englumafusp alfa with glofitamab
  3. Part III: Dose expansion stage using the combination determined to be most effective

The trial aims to evaluate the safety, how the drug behaves in the body (pharmacokinetics), and preliminary effectiveness against NHL[1].

Treatment Combinations

Englumafusp alfa is being studied in combination with other cancer drugs to potentially enhance its effectiveness[1]:

  • Obinutuzumab (also known as Gazyva or Gazyvaro): A targeted therapy that helps the immune system attack cancer cells
  • Glofitamab (also known as CD20-TCB): Another targeted therapy being developed for lymphoma
  • Tocilizumab (also known as Actemra or RoActemra): A medication used to manage potential side effects, specifically cytokine release syndrome

Potential Benefits

The clinical trial is assessing several potential benefits of englumafusp alfa[1]:

  • Overall Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears
  • Disease Control Rate (DCR): The percentage of patients whose disease remains stable or improves
  • Duration of Response (DOR): How long the cancer remains controlled
  • Progression-free Survival (PFS): The length of time patients live without their cancer worsening
  • Overall Survival (OS): How long patients survive after starting treatment
  • Complete Response (CR): The disappearance of all signs of cancer

Safety and Side Effects

As with any new treatment, monitoring for potential side effects is a crucial part of the clinical trial[1]. The study is closely tracking:

  • The nature and frequency of dose-limiting toxicities (side effects severe enough to prevent increasing the dose)
  • The incidence, nature, and severity of adverse events (side effects)
  • The potential for cytokine release syndrome, a condition where the immune system becomes overactive

Patients in the trial may receive tocilizumab to manage cytokine release syndrome if it occurs[1].

Quality of Life Considerations

The clinical trial is also assessing how englumafusp alfa treatment might affect patients’ quality of life[1]. This includes evaluating:

  • Physical function: The ability to perform daily activities
  • Role function: The ability to work or engage in usual activities
  • Overall health-related quality of life

These assessments use standardized questionnaires designed specifically for cancer patients and those with lymphoma[1].

Aspect Details
Drug Name Englumafusp alfa (RO7227166)
Target CD19 (a protein on B-cells)
Condition Relapsed/Refractory Non-Hodgkin’s Lymphoma
Trial Phase Phase I/II
Administration Intravenous infusion every 3 weeks
Combinations With obinutuzumab and glofitamab
Primary Outcomes Safety, toxicity, response rates, disease control
Secondary Outcomes Pharmacokinetics, immune cell status, quality of life

FAQ

  • What is Englumafusp alfa? Englumafusp alfa is a new drug that targets CD19, a protein found on B-cells. It's being studied as a potential treatment for relapsed or refractory Non-Hodgkin's Lymphoma (NHL).
  • How is Englumafusp alfa administered in the clinical trial? In the trial, Englumafusp alfa is given through an intravenous (IV) infusion every three weeks. It's being tested in combination with other drugs like obinutuzumab and glofitamab.
  • What are the main goals of the clinical trial? The main goals are to evaluate the safety, how well the body processes the drug (pharmacokinetics), and how effective it is in treating NHL. The study also looks at how long the treatment effects last and how it impacts patients' quality of life.
  • Who can participate in this clinical trial? The trial is for patients with relapsed or refractory Non-Hodgkin's Lymphoma. This includes specific types like diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, and others.
  • What are some of the outcomes being measured in the trial? The trial is measuring several outcomes, including the overall response rate to the treatment, how long the response lasts, progression-free survival, and overall survival. It's also closely monitoring any side effects or adverse events.

Ongoing Clinical Trials on Englumafusp Alfa

  • Study on the Safety and Effects of Englumafusp Alfa with Obinutuzumab and Glofitamab for Patients with Relapsed/Refractory B-Cell Non-Hodgkin’s Lymphoma

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Denmark France Italy Spain

Glossary

  • Non-Hodgkin's Lymphoma (NHL): A type of cancer that starts in white blood cells called lymphocytes, which are part of the body's immune system.
  • Relapsed/Refractory (r/r): Refers to cancer that has returned after treatment (relapsed) or has not responded to initial treatment (refractory).
  • Intravenous (IV) infusion: A method of delivering medications directly into a vein using a needle or tube.
  • Pharmacokinetics: The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and excreted.
  • Cytokine Release Syndrome (CRS): A condition that can occur as a side effect of certain cancer treatments, causing symptoms like fever, nausea, and headache.
  • Dose-limiting toxicity (DLT): Side effects of a drug that are severe enough to prevent an increase in dose or require a dose to be decreased.
  • Overall Response Rate (ORR): The percentage of patients whose cancer shrinks or disappears after treatment.
  • Progression-free Survival (PFS): The length of time during and after treatment that a patient lives with the disease without it getting worse.
  • Overall Survival (OS): The length of time from the start of treatment that patients are still alive.
  • Anti-Drug Antibody (ADA): Antibodies that the body produces against a therapeutic drug, which can potentially reduce the drug's effectiveness.

References

  1. https://clinicaltrials.gov/study/NCT04077723