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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for solid tumors, which are abnormal masses of tissue that usually do not contain cysts or liquid areas. The study involves testing genetically modified T-cells, which are a type of immune cell taken from the patient, altered in a lab to better recognize and attack cancer cells, and then infused back into the patient. The treatments being tested include IMA203 and IMA203CD8, both of which are forms of cell therapy, as well as a medication called nivolumab, also known by its code name BMS936558, which is used to help the immune system fight cancer.

The purpose of the study is to evaluate the safety and effectiveness of these treatments, either alone or in combination. The study is divided into two phases. In the first phase, researchers will assess how safe and tolerable the treatments are and determine the best dose to use. In the second phase, the focus will be on how well the treatment works against the tumors. Participants will receive the treatments through an intravenous infusion, which means the medication is given directly into a vein.

Throughout the study, researchers will monitor participants for any side effects and measure how the tumors respond to the treatment. The study aims to find out if these new treatments can help control or reduce the size of the tumors in patients with solid tumors that have returned or are resistant to other treatments. The trial is expected to continue until the end of 2028.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the presence of advanced or metastatic solid tumors with specific tumor target expression.
Eligibility criteria include being 18 years or older, having a performance status of 0 to 1, confirmed HLA status, and adequate organ function.
Step 2
Treatment phase I
In Phase I, the focus is on evaluating the safety and tolerability of the treatment. This involves administering genetically modified T-cells, known as IMA203 or IMA203CD8, either alone or in combination with nivolumab.
The treatment is given through intravenous infusion. The goal is to determine the maximum tolerated dose and the recommended dose for further study.
Step 3
Treatment phase II
In Phase II, the treatment continues with a focus on evaluating the initial anti-tumor activity of IMA203 as a monotherapy.
The treatment is administered through intravenous infusion and aims to assess the objective response rate, which includes complete and partial responses to the treatment.
Step 4
Monitoring and follow-up
Throughout the trial, monitoring for treatment-emergent adverse events and serious adverse events is conducted to ensure patient safety.
Regular follow-up visits are scheduled to assess the patient's response to the treatment and to monitor for any potential side effects.

Who can join the trial?

7 criteria

Patient must have a confirmed advanced and/or metastatic solid tumor with a specific tumor target expression. A solid tumor is a mass of cancer cells that does not include liquid areas or cysts.
Patients must be 18 years of age or older.
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. This is a scale used to assess how a patient's disease is progressing, including their ability to perform daily activities.
Patients must have a confirmed HLA status. HLA stands for human leukocyte antigen, which is a part of the immune system.
Patients must have adequate liver and kidney function, acceptable blood clotting status, and adequate organ and bone marrow function.
Patients must have measurable disease according to RECIST 1.1. RECIST is a set of rules that define when cancer patients improve, stay the same, or worsen during treatments.
Patients must have recovered from infections to Grade 1 or lower if they are in the Nivolumab combination arm. This means the infection should be mild or almost gone.

Who cannot join the trial?

10 criteria

Patients with certain types of cancer called solid tumors cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
Patients who do not meet the specific health requirements set by the study cannot participate.
Patients who are not able to follow the study procedures or instructions cannot participate.
Patients who have other medical conditions that might interfere with the study cannot participate.
Patients who are taking medications that might interfere with the study cannot participate.
Patients who have allergies or reactions to the study treatment cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently cannot participate.

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Verified sites

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Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
Mainz, Germany
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Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
Verified
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Munich, Germany

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Investigated drugs

ACTengine® IMA203
is a treatment involving genetically modified T cells. These T cells are taken from the patient's own body and are altered to recognize and attack cancer cells. This therapy is being tested to see if it can be used alone to treat certain types of solid tumors that have come back or are not responding to other treatments.
ACTengine® IMA203CD8
is similar to IMA203, but it includes an additional modification to enhance the T cells' ability to fight cancer. This therapy is also being tested to determine its safety and effectiveness when used alone or in combination with other treatments.
Nivolumab
is a medication that helps the immune system recognize and attack cancer cells. It is being tested in combination with the modified T cell therapies to see if it can improve their effectiveness in treating solid tumors.

What is already known about the treatment

ACTengine® IMA203 – This medication is administered through genetically modified autologous T cells, which are introduced into the patient's body to target cancer cells. It is currently being studied in clinical trials for its effectiveness against recurrent and/or refractory solid tumors. The main therapeutic indication is for treating these types of tumors, either as a standalone treatment or in combination with another drug called nivolumab. At the molecular level, the modified T cells express a T-cell receptor that recognizes specific cancer antigens, allowing them to target and destroy cancer cells. This medication falls under the pharmacological classification of immunotherapy, specifically involving T-cell receptor-engineered T cells.

Investigated diseases

Solid Tumors – Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. They can occur in various parts of the body, including organs and bones. These tumors are characterized by the uncontrolled growth of cells that form a solid mass. As they progress, they may invade nearby tissues and organs, potentially causing physical symptoms depending on their location. Solid tumors can vary greatly in size and growth rate, and their progression can lead to changes in the function of affected organs. The behavior of solid tumors can differ significantly based on their type and location within the body.