UCB subsidiary Candid Therapeutics has opened a first-in-human Phase I trial of CND319, a dual-targeting T-cell engager (TCE) designed to engage CD3 on T cells while targeting CD19 and CD20 on B cells, in healthy volunteers and patients with rheumatoid arthritis (RA) or Sjögren's disease. CND319 becomes the third TCE in Candid’s portfolio to enter human testing, following cizutamig and CND261.
The open-label, single and multiple ascending dose study (NCT07712939) enrolls up to 105 participants across two parts: a dose-escalation phase in healthy adults followed by an expansion cohort in patients with moderately to severely active RA or primary Sjögren's disease. The study is recruiting at a single site in Melbourne, Australia, with a primary completion date of Q1 2028. Secondary endpoints include standard pharmacokinetic parameters and anti-drug antibody assessments.
CND319 is a CD19×CD20×CD3 trispecific antibody designed to redirect CD3-expressing T cells against B-cell populations expressing CD19, CD20 or both antigens. The two indications selected for the patient expansion — RA and Sjögren's disease — both involve pathogenic B-cell activity and autoantibody production, providing a mechanistic rationale for deeper depletion of autoreactive B-cell populations.
CND319 enters the clinic as Candid's pipeline broadens beyond its two lead assets. Cizutamig, a BCMA-targeting TCE, has been dosed in more than 80 patients across autoimmune and oncology indications, with Phase II studies in myasthenia gravis and interstitial lung disease planned for 2026. CND261, a CD20 TCE, has been administered to over 100 patients. CND319's dual CD19/CD20 format is designed to differentiate from CND261 by adding CD19 coverage, potentially capturing B-cell subsets that downregulate CD20.
The autoimmune TCE field is expanding rapidly, with clinical programs engaging CD3 against B-cell or plasma-cell antigens including CD19, CD20, and BCMA. CND319 is differentiated by combining CD19 and CD20 recognition within a single CD3-engaging trispecific antibody.