YK012 / Excyte - LARVOL DELTA

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of YK012 (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Excyte Biopharma Ltd | Trial completion date: Dec 2026 ➔ Dec 2028 | Trial primary completion date: Jun 2026 ➔ Dec 2028

Trial completion date • Trial primary completion date • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma

Rapid Immune Modulation in Systemic Lupus Erythematosus Through T-Cell–Redirected Depletion of CD19⁺ B Cells After Single Target Dose (FOCIS 2026) - "Strikingly, early clinical improvements were observed, including rapid reductions in SLEDAI-2K scores within weeks after just one target dose of YK012 treatment.ConclusionsTargeted T-cell–mediated B-cell depletion with YK012 demonstrated a manageable safety profile and rapid immunologic activity in patients with SLE. The combination of controlled CRS, profound B-cell depletion, and early improvements in serologic and clinical disease measures supports further evaluation of YK012 as a potential immune-resetting therapy for broad autoimmune diseases."

Immune Modulation • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • CD19

Study of YKST02 Alone or in Combination With YK012 in Patients With Active or Refractory Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

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

Study of YK012 in Moderate to Severe Systemic Lupus Erythematosus (clinicaltrials.gov) - P1/2 | N=189 | Recruiting | Sponsor: Excyte Biopharma Ltd | Not yet recruiting ➔ Recruiting

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

A Phase I Study of YK012 in Primary Membranous Nephropathy (clinicaltrials.gov) - P1 | N=66 | Not yet recruiting | Sponsor: Excyte Biopharma Ltd | Initiation date: Feb 2026 ➔ Oct 2026

Trial initiation date • Glomerulonephritis • Renal Disease

A Phase I Study of YK012 in Primary Membranous Nephropathy (clinicaltrials.gov) - P1 | N=66 | Not yet recruiting | Sponsor: Excyte Biopharma Ltd

New P1 trial • Glomerulonephritis • Renal Disease

Study of YK012 in Moderate to Severe Systemic Lupus Erythematosus (clinicaltrials.gov) - P1/2 | N=189 | Not yet recruiting | Sponsor: Excyte Biopharma Ltd | N=144 ➔ 189

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

Study of YK012 in Moderate to Severe Systemic Lupus Erythematosus (clinicaltrials.gov) - P1/2 | N=144 | Not yet recruiting | Sponsor: Excyte Biopharma Ltd

New P1/2 trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Study of YK012 in Primary Membranous Nephropathy (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Excyte Biopharma Ltd

New P1 trial • Glomerulonephritis • Renal Disease

Study of YK012 in B-cell Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1/2 | N=46 | Recruiting | Sponsor: Excyte Biopharma Ltd

New P1/2 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of YK012 (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Excyte Biopharma Ltd

New P1 trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology