cizutamig (EMB-06) / EpimAb Biotherap, UCB - LARVOL DELTA

Pooled safety of cizutamig, a BCMA×CD3 T-cell engager, in patients with autoimmune diseases (ACR Convergence 2026) - No abstract available

Clinical • Immunology

Cizutamig Induces Deep Depletion of Tissue B Cells and Plasma Cells Across Multiple Autoimmune Diseases with Evidence of Immune Reset (ACR Convergence 2026) - No abstract available

Immunology

A Phase I Study of a Novel BCMA×CD3 Bispecific Antibody Emb-06 in Relapsed or Refractory Multiple Myeloma (ASH 2024) - "Notably, patients experiencing treatment delays of at least 3 months due to adverse events (AEs) still exhibited sustained responses in one patient and deepened responses in two patients (from VGPR to CR and from PR to CR, respectively). Conclusions : In this analysis of full dose escalation study, EMB-06 demonstrated a differentiated safety profile in RRMM patients, with low rates of CRS and no ICANS, and durable efficacy in heavily pre-treated RRMM patients."

P1 data • Anemia • Cardiovascular • Congestive Heart Failure • Heart Failure • Hematological Disorders • Hematological Malignancies • Hepatitis C • Infectious Disease • Liver Failure • Multiple Myeloma • Neutropenia • Oncology • Pneumonia • Respiratory Diseases

Absolute Bioavailability Study of Cizutamig in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Candid Therapeutics | Active, not recruiting ➔ Completed

Trial completion

A Phase 1 Study of Cizutamig in IgE Mediated Diseases (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Candid Therapeutics | N=20 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Allergy • Food Hypersensitivity • Immunology

BCMA-directed therapy with cizutamig induces rapid improvement in long-standing systemic sclerosis-associated interstitial lung disease. (PubMed, Rheumatology (Oxford)) - No abstract available

Journal • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Scleroderma • Systemic Sclerosis

Safety and Efficacy of Cizutamig, a BCMAxCD3 bispecific T-cell engager, in Severe Diffuse Cutaneous Systemic Sclerosis (EULAR 2026) - "Low-grade cytokine release syndrome was observed (Grade 1 in Patient 1 following the first dose, and mild Grade 2 based on fever and transient (< 30 min) asymptomatic hypotension (decrease in systolic blood pressure (SBP) to the mid-90s with baseline SBP in 100s-130s) immediately responsive to intravenous fluids in Patient 2 after the first dose); the latter treated with dexamethasone (10mg) and tocilizumab (600mg)...Conclusions BCMA×CD3 bispecific antibody therapy with cizutamig was feasible and generally well tolerated in refractory diffuse cutaneous SSc, inducing deep B- and plasma-cell depletion with signals of clinical improvement or stabilisation. Further studies are required to define durability, optimal use, and long- term safety."

Bispecific • Clinical • Hypotension • Immunology • Infectious Disease • Interstitial Lung Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases • Scleroderma • Systemic Sclerosis • CD20 • SDC1 • TOP1

Clinical safety and evidence of tissue B-cell and plasma cell depletion with cizutamig, a BCMAxCD3 T-cell engager, in patients treated with autoimmune diseases (EULAR 2026) - "Patients received premedication with acetaminophen, antihistamine, and various corticosteroid regimens (dexamethasone or methylprednisolone) prior to the initial doses of cizutamig...Conclusions The data show that cizutamig was generally well tolerated and safe across patients with various AIDs, complemented by deep depletion of B-cells and plasma cells in tissues. These preliminary data support further development of cizutamig in AID."

Clinical • CNS Disorders • Hypotension • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Multiple Myeloma • Myasthenia Gravis • Myositis • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • Rheumatoid Arthritis • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis

A Clinical Study of Cizutamig in Thyroid Eye Disease (clinicaltrials.gov) - P1 | N=38 | Recruiting | Sponsor: Candid Therapeutics

New P1 trial • Ophthalmology • Thyroid Eye Disease

UCB to acquire Candid Therapeutics, building upon its existing immunology pipeline with novel T-cell engagers (UCB Press Release) - "Candid’s lead asset, cizutamig, a bispecific antibody directed to B-cell maturation antigen (BCMA) on plasma cells and CD3 on T-cells, is currently in multiple phase 1 clinical studies across various autoimmune diseases...Under the terms of the agreement, UCB will pay US $2 billion upfront and up to US $200 million in potential future milestone payments. The transaction remains subject to certain closing conditions, including required anti-trust clearance and other customary conditions, and is expected to close by end of Q2 – early Q3 2026."

M&A • Immunology • Inflammatory Bowel Disease • Multiple Myeloma • Myasthenia Gravis • Rheumatoid Arthritis • Systemic Lupus Erythematosus • Systemic Sclerosis • Ulcerative Colitis

Absolute Bioavailability Study of Cizutamig in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: Candid Therapeutics | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2026 ➔ Jun 2026 | Trial primary completion date: Mar 2026 ➔ Jun 2026

Enrollment closed • Trial completion date • Trial primary completion date

TMP-23062025-2: An open label, phase I/II study investigating the safety and efficacy of the bispecific T-cell engaging antibody cizutamig (BCMAxCD3) in patients with immune-mediated inflammatory diseases the SPLENDID Trial (clinicaltrialsregister.eu) - P1/2 | N=12 | Recruiting | Sponsor: Fraunhofer Institute For Translational Medicine And Pharmacology ITMP

New P1/2 trial • Immunology • Inflammation • Inflammatory Arthritis • Myositis • Rheumatoid Arthritis • Rheumatology • Scleroderma • Sjogren's Syndrome • Systemic Sclerosis

A Phase 1 Study of Cizutamig in IgE Mediated Diseases (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Candid Therapeutics

New P1 trial • Allergy • Food Hypersensitivity • Immunology

An Open-label Study of Cizutamig in Refractory Seropositive Rheumatoid Arthritis (clinicaltrials.gov) - P1 | N=28 | Recruiting | Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting ➔ Recruiting | N=19 ➔ 28 | Trial completion date: Nov 2026 ➔ Jun 2027 | Trial primary completion date: Jun 2025 ➔ Jun 2027

Enrollment change • Enrollment open • Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Study of Cizutamig for Patients With Ulcerative Colitis (clinicaltrials.gov) - P1 | N=15 | Not yet recruiting | Sponsor: Ruijin Hospital

New P1 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Absolute Bioavailability Study of Cizutamig in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Candid Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open

Absolute Bioavailability Study of Cizutamig in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Candid Therapeutics

New P1 trial

Clinical Study of Cizutamig in Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=47 | Recruiting | Sponsor: Candid Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Clinical Study of Cizutamig in Generalized Myasthenia Gravis (gMG) (clinicaltrials.gov) - P1 | N=44 | Recruiting | Sponsor: Candid Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Myasthenia Gravis

Study to evaluate Cizutamig in patients with immunoglobulin A nephropathy (ChiCTR) - P=N/A | N=15 | Recruiting | Sponsor: Peking University First Hospital; Peking University First Hospital

New trial • Glomerulonephritis • IgA Nephropathy • Renal Disease

A Phase 1B, Open-label, Multicenter Study Evaluating The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, And Preliminary Clinical Actvity of Cizutamig in Systemic Lupus Erythematosus (ChiCTR) - P1 | N=47 | Not yet recruiting | Sponsor: Peking Union Medical College Hospital; Peking Union Medical College Hospital

New P1 trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Cizutamig, a BCMA T-cell engager: preclinical to clinical translation of design optimization for the treatment of autoimmune diseases (ACR Convergence 2025) - "A patient with rheumatoid arthritis (RA) refractory to 5 targeted synthetic and biologic DMARDs including rituximab was the first non-oncology patient treated with weekly doses of cizutamig. In vitro, cizutamig showed comparable T cell dependent cytotoxicity of BCMA-expressing cell lines with lower cytokine release compared to benchmark BCMA TCEs (Fig 1)... Cizutamig was designed to mitigate cytokine release while preserving cytotoxicity of BCMA-expressing cells. Preclinical and clinical data demonstrate a differentiated safety profile with signs of clinical activity in RRMM patients and a patient with refractory RA. Further clinical evaluation of cizutamig in autoimmune diseases is being explored."

Preclinical • Hematological Malignancies • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Multiple Myeloma • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus • CD20 • SDC1

Clinical Study of Cizutamig in Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=47 | Not yet recruiting | Sponsor: Candid Therapeutics

New P1 trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Clinical Study of Cizutamig in Generalized Myasthenia Gravis (gMG) (clinicaltrials.gov) - P1 | N=44 | Not yet recruiting | Sponsor: Candid Therapeutics

New P1 trial • CNS Disorders • Myasthenia Gravis

A First-In-Human Phase 1 Study of a Novel BCMA×CD3 Bispecific T Cell Engager EMB-06 in Relapsed or Refractory Multiple Myeloma. (PubMed, Am J Hematol) - No abstract available

First-in-human • Journal • P1 data • Hematological Malignancies • Multiple Myeloma • Oncology