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Pegenzileukin

This article explores the use of Pegenzileukin, also known as SAR444245, in clinical trials for the treatment of relapsed or refractory multiple myeloma. As part of a larger study investigating various drug combinations, Pegenzileukin is being tested in combination with Isatuximab to evaluate its effectiveness and safety in patients who have not responded to previous treatments or have experienced a recurrence of their disease.

Table of Contents

What is Pegenzileukin?

Pegenzileukin, also known by its research name SAR444245, is a new drug being studied for the treatment of certain blood cancers[1]. It is classified as a novel agent, which means it’s a relatively new medication with a unique way of working in the body. Pegenzileukin is given to patients through an intravenous (IV) infusion, which means it’s delivered directly into the bloodstream through a vein.

What Condition Does Pegenzileukin Target?

The primary focus of the current research involving Pegenzileukin is on treating relapsed or refractory multiple myeloma (RRMM)[1]. Multiple myeloma is a type of blood cancer that affects plasma cells, which are a crucial part of the immune system. When a patient has relapsed or refractory multiple myeloma, it means that their cancer has either returned after treatment or hasn’t responded well to previous treatments.

How is Pegenzileukin Used?

In the ongoing clinical trial, Pegenzileukin is being tested in combination with another drug called Isatuximab[1]. This combination approach is common in cancer treatment, as it often leads to better results than using a single drug alone. The treatment schedule for Pegenzileukin in this trial is as follows:

  • Pegenzileukin is given every two weeks (Q2W) through an IV infusion
  • Isatuximab is given weekly for the first 4 weeks, then every two weeks after that

Current Clinical Trial

Pegenzileukin is currently being studied in a clinical trial known as the UMBRELLA trial[1]. This trial is testing several new drugs in combination with Isatuximab for treating relapsed or refractory multiple myeloma. The part of the trial focusing on Pegenzileukin is called Substudy 04. This substudy is divided into two main parts:

  1. Part 1 – Dose Finding: This phase aims to determine the safest and most effective dose of Pegenzileukin. Researchers will test up to three different dose levels.
  2. Part 2 – Dose Expansion: Once the best dose is determined, more patients will be treated with this dose to further evaluate its effectiveness and safety.

Potential Benefits

While it’s too early to know for certain, researchers hope that Pegenzileukin, when combined with Isatuximab, might offer several potential benefits for patients with relapsed or refractory multiple myeloma[1]:

  • Improved response rates to treatment
  • Longer-lasting remissions
  • Better quality of life for patients
  • A new option for patients who haven’t responded well to other treatments

Possible Side Effects

As with any new medication, understanding the potential side effects of Pegenzileukin is an important part of the clinical trial[1]. The researchers will be closely monitoring patients for any adverse reactions. Some of the things they’ll be watching for include:

  • Treatment-emergent adverse events (TEAEs)
  • Serious adverse events (SAEs)
  • Changes in laboratory test results
  • Changes in vital signs

It’s important to note that not all patients will experience side effects, and the severity can vary from person to person. If you’re considering participating in a clinical trial or starting a new treatment, always discuss potential risks and benefits with your healthcare provider.

Aspect Details
Drug Name Pegenzileukin (SAR444245)
Condition Treated Relapsed or Refractory Multiple Myeloma (RRMM)
Combination Therapy Used with Isatuximab
Administration Intravenous infusion every two weeks (Q2W)
Trial Structure Part 1: Dose finding and optimization; Part 2: Dose expansion
Primary Outcome Overall Response Rate (ORR)
Treatment Duration Up to approximately 28 months
Safety Assessments Adverse events, serious adverse events, laboratory parameters

FAQ

  • What is Pegenzileukin and how is it being used in clinical trials? Pegenzileukin, also known as SAR444245, is a drug being tested in clinical trials for relapsed or refractory multiple myeloma. It is being used in combination with Isatuximab to evaluate its effectiveness and safety in patients whose cancer has not responded to previous treatments or has come back.
  • How is Pegenzileukin administered in the clinical trial? Pegenzileukin is administered intravenously (through a vein) every two weeks (Q2W). The trial is exploring different dose levels to determine the most effective and safe dosage.
  • What are the different parts of the clinical trial involving Pegenzileukin? The trial has two main parts: Part 1 is the dose-finding and optimization phase, where different dose levels are tested. Part 2 is the dose expansion phase, where the selected dose is further evaluated in a larger group of patients.
  • What is the primary goal of the Pegenzileukin clinical trial? The primary goal of the Pegenzileukin trial is to determine the overall response rate (ORR) in patients. This measures the proportion of patients whose cancer responds to the treatment, showing a reduction in cancer size or disappearance.
  • How long does the treatment with Pegenzileukin last in the clinical trial? Patients in the trial will continue treatment for up to approximately 28 months, or until disease progression, death, unacceptable side effects, or other reasons for stopping treatment as determined by the patient, investigator, or study sponsor.

Ongoing Clinical Trials on Pegenzileukin

  • Study on the Safety and Effects of THOR-707 and Drug Combination in Adults with Advanced or Metastatic Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study of isatuximab and pegenzileukin combination treatment for patients with relapsed or refractory multiple myeloma who previously received anti-CD38 and anti-BCMA therapy

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Greece Italy Norway Portugal

Glossary

  • Pegenzileukin: A drug also known as SAR444245, being tested in clinical trials for the treatment of relapsed or refractory multiple myeloma in combination with Isatuximab.
  • Isatuximab: A drug used in combination with Pegenzileukin in the clinical trial. It is administered intravenously and has other names such as SAR650984 and Sarclisa®.
  • Relapsed or Refractory Multiple Myeloma (RRMM): A condition where multiple myeloma (a type of blood cancer) has either returned after initial treatment or has not responded to treatment.
  • Intravenous (IV): A method of administering medication directly into a vein.
  • Overall Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Dose Level (DL): Different amounts of a drug given to patients in a clinical trial to determine the most effective and safe dose.
  • Q2W: An abbreviation meaning 'every two weeks', referring to how often a medication is administered.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Adverse Events (AEs): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Serious Adverse Events (SAEs): An adverse event that results in death, is life-threatening, requires hospitalization, or causes significant disability.

References

  1. https://clinicaltrials.gov/study/NCT04643002