CNTY-101

Table of contents

• What is CNTY-101?
• How does CNTY-101 work?
• Which conditions is it studied for?
• How is CNTY-101 given?
• What do the clinical trials show?
• What side effects are known?

What is CNTY-101?

CNTY-101 is an investigational cell therapy, meaning it is not yet an authorised medicine. It is a suspension for intravenous infusion developed by Century Therapeutics, Inc.^[1] The substance is classified as a structurally diverse cell therapy and belongs to the therapeutic area of immune system diseases.^[1] The product records list CNTY-101 as the only name for this substance, and it appears as the test substance in one clinical trial.^[1]

How does CNTY-101 work?

CNTY-101 is made from allogeneic induced pluripotent stem cell (iPSC)-derived natural killer (NK) cells that express a chimeric antigen receptor (CAR). The trial title describes it as a CAR-expressing cell therapy intended to deplete B cells, which are immune cells involved in certain autoimmune diseases.^[1] By targeting B cells, the therapy aims to reduce the abnormal immune response that drives conditions such as lupus and systemic sclerosis. The trial also includes aldesleukin, a form of interleukin-2 given as a subcutaneous injection, which is used to support the NK cells.^[1]

Which conditions is it studied for?

• Systemic lupus erythematosus (SLE) — a chronic autoimmune disease where the immune system attacks healthy tissues, causing inflammation and organ damage.
• Systemic sclerosis — a rare autoimmune condition that causes hardening and tightening of the skin and connective tissues, and can affect internal organs.
• Idiopathic inflammatory myositis — a group of rare autoimmune muscle diseases that cause muscle weakness and inflammation.

All three conditions are B-cell driven autoimmune diseases, meaning B cells play an important role in causing the immune system to attack the body.^[1]

How is CNTY-101 given?

CNTY-101 is given as a suspension for intravenous infusion, which means it is administered directly into a vein.^[1] In the trial, it is given together with aldesleukin, which is injected under the skin (subcutaneously).^[1] The trial records do not state the specific dose or schedule for CNTY-101.

What do the clinical trials show?

There is one clinical trial of CNTY-101 in the registry, a Phase 1 study called CARAMEL. The trial is currently authorised and plans to enroll 12 participants with active B-cell driven autoimmune disease.^[1] The study is interventional and focuses on assessing safety. The main outcome measure is the incidence of several immune-related side effects, including graft-versus-host disease (GvHD), cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), immune effector cell-associated hemophagocytosis, and organ toxicity.^[1] Because this is a Phase 1 trial, the primary goal is to understand how safe the treatment is, rather than to prove how well it works.

What side effects are known?

The trial is designed to detect and measure specific side effects that can occur with CAR cell therapies. These include cytokine release syndrome (CRS), a condition where the immune system becomes overactive and causes fever, low blood pressure, and breathing problems; immune effector cell-associated neurotoxicity syndrome (ICANS), which affects the nervous system and can cause confusion, seizures, or difficulty speaking; graft-versus-host disease (GvHD), where donor cells attack the patient's body; and immune effector cell-associated hemophagocytosis, a serious condition involving excessive immune activation.^[1] The trial also monitors organ toxicity that does not resolve within 72 hours. These are being measured as safety outcomes, not as confirmed side effects of CNTY-101.