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Ima203Cd8

In the realm of cancer treatment, a groundbreaking clinical trial is underway to evaluate the potential of IMA203CD8, a genetically modified T-cell therapy. This innovative approach aims to target recurrent and refractory solid tumors by harnessing the power of a patient’s own immune system. The trial explores the safety, tolerability, and anti-tumor activity of IMA203CD8, both as a standalone treatment and in combination with nivolumab, a known immunotherapy drug.

Table of Contents

What is IMA203CD8?

IMA203CD8 is an innovative treatment being studied for patients with advanced and/or metastatic solid tumors[1]. It belongs to a class of treatments called cell therapies, which involve using modified cells from a patient’s own body to fight cancer[1]. Specifically, IMA203CD8 is categorized as a genetically modified autologous T cell therapy. This means that it uses T cells (a type of immune cell) taken from the patient, which are then altered in a laboratory to better recognize and attack cancer cells[1].

How Does IMA203CD8 Work?

IMA203CD8 works by enhancing the body’s natural defense system against cancer. Here’s a simplified explanation of the process:

  1. T cells are collected from the patient’s blood.
  2. These T cells are genetically modified in a laboratory to express a special T-cell receptor (TCR).
  3. This TCR is designed to recognize a specific cancer/germline antigen, which is a protein found on cancer cells.
  4. The modified T cells (now called IMA203CD8) are then infused back into the patient.
  5. These engineered T cells can now better identify and attack cancer cells that have the specific antigen they’re programmed to recognize.

This approach is part of a broader category of treatments called immunotherapy, which aims to harness the power of the body’s immune system to fight cancer[1].

Who Might Benefit from IMA203CD8?

IMA203CD8 is being studied for patients with:

  • Advanced solid tumors: These are cancers that form solid masses in the body, such as in the lungs, breast, or colon.
  • Metastatic cancers: This refers to cancers that have spread from their original location to other parts of the body.
  • Recurrent cancers: These are cancers that have come back after initial treatment.
  • Refractory cancers: These are cancers that don’t respond well to standard treatments[1].

It’s important to note that patients must have tumors with a specific antigen expression that the IMA203CD8 cells are designed to recognize[1].

Clinical Trial Details

IMA203CD8 is currently being studied in a Phase 1/2 clinical trial. This means it’s in the early stages of testing in humans. The trial is designed to:

  1. Evaluate the safety and tolerability of IMA203CD8
  2. Determine the best dose to use
  3. Assess how well it works against tumors[1]

The trial is divided into different phases:

  • Phase Ia: This is the dose escalation/de-escalation phase, where researchers try to find the right dose of IMA203CD8.
  • Phase Ib: This is the dose extension phase, where the chosen dose is tested in more patients to confirm its safety and see how well it works[1].

Treatment Approaches

The clinical trial is testing IMA203CD8 in several different ways:

  • IMA203CD8 alone (monotherapy): Some patients will receive only IMA203CD8.
  • IMA203CD8 with nivolumab: Some patients will receive IMA203CD8 combined with another immunotherapy drug called nivolumab.
  • IMA203CD8 with or without IL-2: Some patients may receive IMA203CD8 with or without a substance called IL-2, which can help T cells grow and function better[1].

These different approaches are being tested to see which one might work best for patients.

Safety and Effectiveness Evaluation

The researchers are closely monitoring patients for any side effects or adverse reactions to the treatment. They’re particularly interested in:

  • Treatment-emergent adverse events (TEAEs): These are any unfavorable medical events that occur after starting the treatment.
  • Adverse Events of special interest (AESIs): These are specific side effects that the researchers are particularly watching for.
  • Serious TEAEs: These are severe adverse events that may require hospitalization or are life-threatening.
  • Dose-limiting toxicities: These are side effects severe enough to prevent increasing the dose further[1].

To measure how well IMA203CD8 works against tumors, the researchers are looking at the objective response rate. This includes checking if tumors shrink completely (complete response) or partially (partial response) after treatment[1].

Eligibility Criteria

Not all patients with solid tumors are eligible for this trial. Some key eligibility criteria include:

  • Age 18 or older
  • Confirmed advanced and/or metastatic solid tumor with specific tumor target expression
  • Good overall health status (ECOG performance status 0 to 1)
  • Measurable disease according to specific criteria (RECIST 1.1)
  • Adequate organ function[1]

There are also several factors that might exclude a patient from the trial, such as:

  • History of other cancers or active brain metastases
  • Pregnancy or breastfeeding
  • Prior stem cell or organ transplantation
  • Severe immune-related side effects from previous immunotherapy treatments[1]

It’s important to note that this is a complex treatment still in the early stages of research. Patients interested in this or similar trials should discuss their options thoroughly with their healthcare team.

Aspect Details
Study Type Phase 1/2 clinical trial
Treatment IMA203CD8 (genetically modified T-cells)
Administration Intravenous infusion
Target Population Adults with advanced/metastatic solid tumors
Study Phases Phase Ia (dose escalation), Phase Ib (dose extension), Phase II
Treatment Arms IMA203 monotherapy, IMA203 + nivolumab, IMA203CD8 + nivolumab, IMA203CD8 monotherapy
Primary Endpoints Safety, tolerability, adverse events, maximum tolerated dose, objective response rate
Key Eligibility Criteria Age ≥18, confirmed tumor target expression, ECOG status 0-1, measurable disease

FAQ

  • What is IMA203CD8? IMA203CD8 is a type of genetically modified T-cell therapy. It involves altering a patient's own T-cells to express a specific receptor that can recognize and target cancer cells.
  • Who is eligible for this clinical trial? Eligible participants are adults (18 years or older) with advanced or metastatic solid tumors that express a specific tumor target. They must have measurable disease and meet certain health criteria, including adequate organ function and an ECOG performance status of 0 to 1.
  • How is IMA203CD8 administered? IMA203CD8 is administered through intravenous infusion. The trial will determine the optimal dose and schedule for treatment.
  • What are the main objectives of this clinical trial? The trial aims to evaluate the safety and tolerability of IMA203CD8, determine the maximum tolerated dose, and assess its initial anti-tumor activity. It will also explore the combination of IMA203CD8 with nivolumab.
  • What are the potential side effects of this treatment? While specific side effects are not mentioned in the provided information, the trial will closely monitor for treatment-emergent adverse events, serious adverse events, and adverse events of special interest to ensure patient safety.

Ongoing Clinical Trials on Ima203Cd8

  • Study on Treating Solid Tumors with Genetically Modified T-Cells (IMA203, IMA203CD8) and Nivolumab for Patients with Recurrent or Refractory Conditions

    Recruiting

    2 1 1 1
    Investigated drugs:
    Germany

Glossary

  • T-cell therapy: A type of treatment that uses a patient's own immune cells (T-cells) to fight cancer. The T-cells are modified in a laboratory to better recognize and attack cancer cells.
  • Solid tumor: A mass of abnormal cells that does not contain cysts or liquid areas. Solid tumors can occur in various parts of the body, such as the breast, lung, or colon.
  • Recurrent cancer: Cancer that has returned after a period of time during which it could not be detected. It may come back in the same place as the original tumor or in another part of the body.
  • Refractory cancer: Cancer that does not respond to treatment. It may be resistant at the beginning of treatment or become resistant during treatment.
  • Nivolumab: An immunotherapy drug that helps the immune system fight cancer cells. It belongs to a class of drugs called checkpoint inhibitors.
  • ECOG performance status: A scale used to assess how a patient's disease is progressing and how it affects daily living abilities. It ranges from 0 (fully active) to 5 (death).
  • Maximum tolerated dose (MTD): The highest dose of a drug or treatment that does not cause unacceptable side effects.
  • Recommended dose for extension (RP2D): The dose of a drug recommended for further study in larger clinical trials based on safety and efficacy data from earlier phase studies.
  • RECIST 1.1: Response Evaluation Criteria in Solid Tumors, version 1.1. It's a standard way to measure how well a cancer patient responds to treatment.
  • HLA status: Human Leukocyte Antigen status. HLAs are proteins on cells that help the immune system identify which cells belong in the body and which do not.

References

  1. http://clinicaltrials.eu/trial/study-on-treating-solid-tumors-with-genetically-modified-t-cells-ima203-ima203cd8-and-nivolumab-for-patients-with-recurrent-or-refractory-conditions/