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Long‑term safety of IMA203 and IMA203CD8 autologous T‑cell therapy in patients with previously treated advanced or metastatic solid tumors

Verified siteInvestigationalNo placebo

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What is this trial about?

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

Patients with previously treated, advanced or metastatic solid tumors are being studied. The investigational treatment uses the patient’s own immune cells (autologous T cells) that are genetically changed with a harmless virus (lentiviral vector) so they produce a special protein called a T‑cell receptor that can recognize a cancer‑related protein named PRAME. Two versions of this cell therapy are being tested, identified as IMA203 and IMA203CD8. The modified cells are given by an intravenous infusion, which means they are delivered directly into a vein.

The purpose of the study is to evaluate the long‑term safety of the therapy up to 15 years after the infusion. After receiving a single infusion, participants will attend regular clinic visits where doctors will check their health with physical exams, blood tests, and imaging scans to look for any delayed side effects. Follow‑up continues for many years, allowing researchers to collect information on any late‑appearing adverse events.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Baseline assessments
After enrollment, doctors will review your medical history and may ask you to provide blood samples and imaging studies such as scans. these tests help determine your current health status before receiving the study treatment.
Step 2
Collection of your own t-cells
A small amount of blood will be drawn to collect your t-cells, which are a type of immune cell that normally help fight infections. because the treatment uses autologous t-cells, the cells come from your own body.
Step 3
Manufacturing of modified t-cells
The collected t-cells are sent to a specialized laboratory where they are genetically altered using a lentiviral vector called lv-r11kea. this process creates the study medication, either ima203 or ima203cd8. you will not need to do anything during this laboratory phase, but you may be asked to wait for a period of several weeks while the cells are prepared.
Step 4
Intravenous infusion of study medication
Once the modified t-cells are ready, you will receive a single intravenous infusion (a medication given through a vein). the infusion is administered in a clinical setting and may take several hours. the exact amount of cells infused is not specified in the study information, but the infusion is given only once.
Step 5
Immediate post‑infusion monitoring
After the infusion, you will be observed for a period of several hours to a few days. medical staff will check your vital signs, look for any reactions, and may perform additional blood tests to ensure safety.
Step 6
Short‑term follow‑up visits
Within the first few weeks after infusion, you will attend scheduled visits. these appointments typically occur at about one week, one month, and three months after treatment. during each visit, doctors will perform physical examinations, ask about any symptoms, and may repeat blood tests or imaging to monitor your condition.
Step 7
Long‑term follow‑up
The study continues to monitor your safety for up to fifteen years after the infusion. you will be asked to return for regular check‑ups, often every six months, during which the same safety assessments (physical exam, symptom review, and selected tests) will be performed. the purpose of these visits is to identify any delayed adverse events that may arise long after the treatment.

Who can join the trial?

5 criteria

You must have already taken part in an earlier study and received at least one infusion of the IMA203 or IMA203CD8 product. (Infusion means the treatment was given through a needle directly into your bloodstream.)
You can be either male or female.
You can be any age, including children and adults.
The study can include people who are considered vulnerable (for example, individuals who may have difficulty making decisions on their own).
You must have a solid tumor. (Solid tumor is a type of cancer that forms a solid mass, rather than spreading through the blood.)

Who cannot join the trial?

1 criterion

Being unable or unwilling to give written informed consent (a signed document that shows you understand the study and agree to join) or to follow the study’s rules and visits.

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Verified sites

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Verified
Technische Universitaet Dresden
Dresden, Germany

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Investigated drugs

IMA203
is a personalized cell therapy made from a patient’s own T‑cells. The cells are taken from the patient, then genetically modified in the lab using a lentiviral vector (LV‑R11KEA) to give them a new receptor that can recognize tumor‑associated proteins specific to that patient’s cancer. After the modification, the engineered T‑cells are given back to the patient through an intravenous infusion, where they are intended to seek out and attack cancer cells.
IMA203CD8
is a similar autologous T‑cell therapy, but it is specially prepared to contain a higher proportion of CD8‑positive T‑cells, which are the type of immune cells that directly kill tumor cells. Like IMA203, the patient’s own cells are collected, modified to express a tumor‑targeting receptor, and then infused back into the patient to help the immune system fight the cancer.

What is already known about the treatment

IMA203
This therapy is given as an intravenous infusion of a sterile dispersion that contains the patient’s own T‑cells, which have been genetically modified with a lentiviral vector to express a new T‑cell receptor that recognizes the patient’s tumor‑associated antigens. The product is still investigational and is being studied in clinical trials to assess long‑term safety in people with advanced solid tumors that have already been treated. It is intended to help the immune system find and destroy cancer cells by directing the engineered T‑cells to bind specifically to the tumor markers. IMA203 belongs to the class of autologous gene‑modified T‑cell therapies (a type of cell‑based immunotherapy).
IMA203CD8
This medicine is also administered by intravenous infusion and contains the patient’s own CD8‑enriched T‑cells that have been engineered with the same lentiviral construct to target tumor‑associated antigens. Like IMA203, it is an investigational product being evaluated in clinical studies for safety in patients with previously treated, metastatic solid tumors. The CD8 T‑cells are programmed to seek out and kill cancer cells that display the specific antigens, providing a targeted immune attack. IMA203CD8 is classified as an autologous gene‑engineered T‑cell therapy, a form of cellular immunotherapy.

Investigated diseases

Solid tumor - A solid tumor is an abnormal mass of tissue that develops in organs such as the breast, lung, colon, or pancreas. It grows by the uncontrolled division of cells, forming a palpable lump or lesion. As the tumor enlarges, it can invade nearby structures and disrupt normal organ function. Over time, cells may break away and travel through the bloodstream or lymphatic system to form new growths in distant parts of the body. This process of spreading is called metastasis, which changes the disease from a localized to a systemic condition.