In short
CND261 is an investigational protein-based medicine, a CD3/CD20 bispecific T-cell engager, being studied in one clinical trial for active, treatment refractory ANCA-IgG-positive associated vasculitis. The trial is a Phase 1/2 study with 8 participants and is currently authorised in the EU. It is given as an intravenous infusion and has no marketing authorisation.
CND261 is an investigational protein-based medicine being studied in one clinical trial for active, treatment refractory ANCA-IgG-positive associated vasculitis. It is a CD3/CD20 bispecific T-cell engager, a type of antibody designed to bring immune T cells into contact with B cells. The substance is given as a solution for intravenous infusion and has no marketing authorisation in the product records.
Key points
- CND261 is a CD3/CD20 bispecific T-cell engager being tested in one Phase 1/2 trial.
- The trial includes 8 participants with active, treatment refractory ANCA-IgG-positive associated vasculitis.
- The study is currently authorised in the EU Clinical Trials Information System.
- The primary outcomes are safety and the ANCA seroconversion rate at week 24.
- CND261 is given as a solution for intravenous infusion.
- CND261 has no marketing authorisation and is an investigational substance.
What is CND261?
CND261 is a protein-based substance, specifically a CD3/CD20 bispecific T-cell engager. It is classified under immune system diseases in the trial registry. The substance is being developed by Candid Therapeutics Inc. and appears in the registry under the single product name CND261. It has no marketing authorisation in the product records, meaning it is still an investigational substance.
How does CND261 work?
CND261 is described in the trial record as a CD3/CD20 bispecific T-cell engager. CD3 is a protein found on T cells, the immune cells that can attack other cells, while CD20 is found on B cells, the immune cells that produce antibodies. A bispecific engager binds to both at once, bringing T cells into contact with B cells. In ANCA-associated vasculitis, B cells produce the ANCA antibodies that are thought to drive the disease, so engaging T cells to target CD20-positive B cells is the intended mechanism.
Which conditions is CND261 studied for?
- Active, treatment refractory, ANCA-IgG-positive associated vasculitis — a form of autoimmune vasculitis in which antibodies called ANCA (anti-neutrophil cytoplasmic antibodies) attack small blood vessels, and which has not responded to previous treatment.
How is CND261 given?
CND261 is given as a solution for infusion, administered by intravenous infusion. The trial record does not report a specific dose.
What do the clinical trials show?
One clinical trial of CND261 is registered in the EU Clinical Trials Information System. The RENEWAL study is an open-label Phase 1/2 trial with 8 participants, currently authorised. It is interventional and includes only people with active, treatment refractory, ANCA-IgG-positive associated vasculitis.
The Phase 1 part of the study measures safety, specifically the incidence and severity of cytokine release syndrome (CRS), immune cell associated neurotoxicity syndrome (ICANS), and treatment-related adverse events and serious adverse events up to 28 days after the last administration of CND261. The Phase 2 part measures both safety and the ANCA seroconversion rate — the percentage of patients whose ANCA antibodies return to normal at week 24, with normal anti-PR3 antibodies for patients with granulomatosis with polyangiitis (GPA) and normal anti-MPO antibodies for patients with microscopic polyangiitis (MPA).
What side effects are known?
No side effect data are provided in the supplementary sources for CND261.