A Clinical Study of the Safety and Effectiveness of an Investigational Cell Therapy Given With and Without an Investigational RNA-based Vaccine in Patients With Organ Tumors
This research study is looking into a new way to treat certain advanced solid tumors. It uses a special cell therapy called CLDN6 CAR-T, sometimes combined with an experimental vaccine that also targets CLDN6. The main goals are to check how safe these treatments are and if they can help shrink tumors in people whose cancer has relapsed (come back) or is refractory (not responding to other treatments) and has the CLDN6 marker. This is an early-stage study, meaning it's one of the first times these treatments are being tested in humans. Participants will be carefully monitored for both short-term and long-term effects of the treatment.
At a glance
What is this study about?
This study is investigating a new type of treatment for advanced solid tumors, which are cancers that have grown or spread in different parts of the body. The treatment involves a special kind of cell therapy, sometimes given along with an experimental vaccine. The cell therapy uses your own immune cells, called T-cells, which are collected from your body and then specially trained in a lab to recognise and fight cancer cells that have a specific marker called CLDN6 on their surface. These trained cells are then put back into your body.
The main purpose of this early-stage study is to understand if these new treatments are safe for people with these types of cancer. It also aims to see if they show any promising signs of working against the cancer. Doctors will be looking for the best dose of the cell therapy, both on its own and when combined with the experimental vaccine, to make sure it's as effective and as safe as possible.
This is a 'first-in-human' study, which means it's among the initial times these specific treatments are being tested in people. Because these are new and experimental treatments, the study will involve careful monitoring of participants for a long time, sometimes up to 15 years, to ensure their safety and track how they are doing in the long term.
Key takeaways
- This is an early-stage study testing a new cell therapy (CAR-T) and a vaccine for advanced solid tumors.
- The treatment targets a specific marker on cancer cells called CLDN6.
- The main goals are to find out if the treatments are safe and what the best dose is.
- Participation requires your tumor to have the CLDN6 marker and you must be over 18.
- The study involves monitoring your health closely for up to 2 years, with an optional long-term follow-up for up to 15 years.
- Potential benefits include possible tumor shrinkage, but there are also known and unknown risks.
Who may be eligible?
To join this study, you would need to have certain types of cancer that have spread or haven't responded to previous treatments. A key requirement is that your tumor must show a specific marker called CLDN6. This will be checked using a sample of your tumor tissue. If your tumor doesn't have enough of this marker, you unfortunately wouldn't be able to take part.
You must be at least 18 years old. Doctors will also need to review your overall health, including how well your body systems are working and your general physical condition, to make sure it's safe for you to participate in this type of treatment. You should also be in a general state of health that allows you to cope with the study procedures.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years of age or older?
- Do you have a solid tumor that has spread or hasn't responded to previous treatments?
- Has your doctor confirmed that your tumor has the CLDN6 marker?
- Are you in generally good health apart from your cancer?
What does participation involve?
If you decide to take part, you'll first have screenings to ensure you meet all the study requirements. This includes providing a recent tumor tissue sample to check for the CLDN6 marker. The treatment involves receiving the special cell therapy and potentially a vaccine. You will have regular visits to the hospital for check-ups, blood tests, and scans to monitor your health and how the treatment is affecting your cancer. These visits will be more frequent at the beginning and then become less frequent over time. The main part of the study could last for about two years. After that, because these are new treatments, you'll be asked to participate in a long-term follow-up for up to 15 years. This involves occasional check-ins to make sure you remain safe and healthy, and to see how the treatment has worked over time. You would need to agree to this long-term follow-up separately.
Potential risks and benefits
Locations (12)
- Peter MacCallum Cancer CentreVerified postcodeMelbourne, Australia· Completed
- Charité - Universitätsmedizin Berlin - Campus Benjamin FranklinVerified postcodeBerlin, Germany· Recruiting
- Universitätsklinikum Köln AÖR-Centrum für Integrierte Onkologie (CIO)-Studienzentrum der Klinik I für Innere Medizin (CTU Cologne)Verified postcodeCologne, Germany· Recruiting
- Universitätsklinikum Erlangen - Hämatologie & Intrinsische Onkologie - Medizinische Klinik 5Verified postcodeErlangen, Germany· Recruiting
- Universitätsklinikum Hamburg Eppendorf - II Medizinische Klinik und PoliklinikVerified postcodeHamburg, Germany· Recruiting
- Medizinische Hochschule Hannover - Klinik für Hämatologie, Hämostaseologie, Onkologie und StammzelltransplantationVerified postcodeHanover, Germany· Recruiting
- Nationales Centrum für Tumorerkrankungen (NCT) HeidelbergVerified postcodeHeidelberg, Germany· Recruiting
- Universitätsmedizin Mainz - III Medizinische Klinik und PoliklinikVerified postcodeMainz, Germany· Recruiting
- Universitätsklinikum Regensburg - Klinik und Poliklinik für Innere Medizin IIIVerified postcodeRegensburg, Germany· Recruiting
- He Nederlands Kanker Instituut (The Netherlands Cancer Institute) - Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL)Verified postcodeAmsterdam, Netherlands· Recruiting
- Erasmus MC - Universitair Medisch Centrum - Medical oncologyVerified postcodeRotterdam, Netherlands· Recruiting
- Karolinska Comprehensive Cancer Center Cancerstudieenheten Huddinge Karolinska UniversitetssjukhusetVerified postcodeStockholm, Sweden· Recruiting
Common questions
What is a 'solid tumor'?
A solid tumor is an abnormal mass of tissue that usually does not contain cysts or liquid areas. Most cancers are solid tumors.
What does CLDN6 mean?
CLDN6 is a specific marker that can be found on the surface of some cancer cells. The treatments in this study are designed to target cancer cells that have this marker.
What is a 'cell therapy'?
Cell therapy involves taking your own immune cells, training them in the lab to fight your cancer, and then giving them back to you.
What is a 'Phase I' study?
A Phase I study is one of the first times a new treatment is tried in people. The main goals are to find out if it's safe and to determine the best dose to use.
Why is there such a long follow-up period?
Because these are new and experimental treatments, especially those that involve altering cells, doctors need to track participants for a long time to understand any potential delayed effects and to see how well the treatment helps them in the long run.
How to find out more
BioNTech clinical trials patient information
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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