Active not recruitingPHASE1, PHASE2INTERVENTIONAL

Comparison of B-cell Depletion by Rituximab and Anti-CD 19 CAR-T Therapy in Patients With Rheumatoid Arthritis

This research study is looking at serious rheumatoid arthritis (RA) in people whose condition hasn't improved with other treatments. It's comparing a new, experimental cell therapy called KYV101 with an established RA medication, Rituximab. The main goal is to understand how safe these two treatments are and how well they work to reduce the disease and a specific marker (ACPA) in the blood. Researchers will also look at how these treatments affect the body's immune system and if they can lead to long-term improvements. Participants will receive one of the treatments and be followed closely for about a year to see how they respond.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Charite University, Berlin, Germany

Enrolment target

Start

04 Dec 2024

Estimated completion

01 Jun 2027

Rheumatoid Arthritis

What is this study about?

This study is designed for people who have rheumatoid arthritis (RA), a condition where the body's immune system mistakenly attacks its own joints, causing pain, swelling, and damage. Specifically, it's for those with a strong form of RA that hasn't gotten better with standard treatments. The study aims to compare two different ways of treating RA: Rituximab, which is an existing medicine, and a new, experimental approach called KYV101. Both treatments work by targeting specific immune cells (B-cells) that are thought to play a role in RA.

The main purpose is to see how safe each treatment is. Researchers also want to find out how well they work to reduce the symptoms of RA and if they can change certain antibodies in the blood called ACPA, which are often found in people with RA and are linked to more severe disease. They will also look at whether these treatments can help people stay well for longer, potentially without needing constant medication.

By comparing these two treatments, the study hopes to find better ways to help people with severe RA that hasn't responded to other treatments. This could lead to new or improved options for managing this challenging condition and improving quality of life for patients.

Key takeaways

This study is for people with severe rheumatoid arthritis that hasn't responded to other treatments.
It compares a new cell therapy (KYV101) with an existing drug (Rituximab).
It aims to check the safety and effectiveness of both treatments.
Participation involves regular clinic visits for about one year.
You will receive either the new cell therapy or the established drug.
Your GP or specialist can help you decide if this study might be right for you.

Who may be eligible?

To join this study, you need to be aged between 18 and 80 years old and have a specific type of Rheumatoid Arthritis. Your RA must still be active despite having tried several other treatments, and you'll need to have certain levels of a marker called ACPA in your blood. You also need to be able to visit the study site regularly for appointments and be willing to have a joint biopsy.

There are also some health conditions that would prevent you from taking part. For example, if you have very low blood cell counts, serious kidney, liver, or heart/lung problems, or if you've already had certain types of cell or gene therapy, you wouldn't be able to join. Your doctors will check all these details carefully to make sure the study is safe for you.

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 between 18 and 80 years old?
Has your rheumatoid arthritis not improved with at least three other treatments?
Do you have a positive ACPA blood test for your rheumatoid arthritis?
Are you able to attend regular appointments for about a year?
Are you willing to undergo a joint biopsy?
Do you have any serious heart, lung, kidney, or liver conditions?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be assigned to one of two treatment groups. One group will receive the new therapy, KYV101, as a one-off drip into a vein. The other group will receive Rituximab, an established RA treatment, given as two drips into a vein, two weeks apart. You might also receive other medications to prepare you for the treatment or to manage any side effects.

After your treatment, you'll have regular hospital visits over 52 weeks (about a year) to monitor your health, check how your RA is responding, and see how you're feeling. These visits will involve various tests and assessments, and the study team will be there to support you throughout.

Potential risks and benefits

Taking part in any research study has potential benefits and risks. You might benefit from receiving a new and potentially effective treatment for your RA, especially if other treatments haven't worked well. However, there's no guarantee that the treatment will work for you, and like all medicines, both KYV101 and Rituximab can have side effects, some of which could be serious. The study team will explain all known risks to you in detail. Remember, joining this study is completely voluntary, and you have the right to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Charité - Universitätsmedizin Berlin
Verified postcode
Berlin, Germany

Common questions

What is KYV101?

KYV101 is a new, experimental cell therapy where some of your own immune cells are specially modified and then given back to you to help fight your rheumatoid arthritis.

What is Rituximab?

Rituximab is a medication already used for rheumatoid arthritis that works by reducing certain immune cells (B-cells) that contribute to the disease.

What does 'ACPA positive' mean?

ACPA positive means a specific type of antibody that is often found in the blood of people with rheumatoid arthritis, indicating a particular form of the disease.

How long will the study last for me?

If you join the study, you'll be followed up for about 52 weeks, which is roughly one year, with regular visits to the clinic.

Will I know which treatment I'm getting?

Yes, in this study, you will know whether you are receiving KYV101 or Rituximab.