Clinical Trials / GCP

Clinical studies conducted or supported by our group in rheumatology and immunology, including innovative approaches such as cell therapies and T-cell engagers.

TCE IIT

Clinical Study of A-319 in the Treatment of Active/Refractory Systemic Lupus Erythematosus

Registration number: NCT06400537
Indication: Active refractory systemic lupus erythematosus
Intervention: A-319 (CD19×CD3 bispecific T-cell engager)

CAR-T Phase I/IIa

A Phase I/IIa Clinical Study to Evaluate Universal Allogeneic CAR-T Cells Targeting CD19 and BCMA (QT-019B) in Patients with Refractory Systemic Lupus Erythematosus

Registration number: CTR20254910
Indication: Refractory systemic lupus erythematosus
Intervention: Universal allogeneic CAR-T cells (QT-019B, targeting CD19/BCMA)

CAR-NK Phase I

A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Preliminary Efficacy of KN5501 Cell Injection (KN5501) in Patients with Moderate-to-Severe Refractory Systemic Lupus Erythematosus (SLE)

Registration number: CTR20255045
Indication: Moderate-to-severe refractory systemic lupus erythematosus
Intervention: KN5501 cell injection (CAR-T-type cell product)

TCE IIT

Clinical Study of (A-319) in the Treatment of Active Rheumatoid Arthritis

Registration number: NCT07347860
Indication: Active rheumatoid arthritis
Intervention: A-319 (CD19×CD3 bispecific T-cell engager)

TCE Early Phase I

An Open-label Study of GB261 in Refractory Seropositive Systemic Lupus Erythematosus

Registration number: NCT06945068
Indication: Refractory seropositive systemic lupus erythematosus
Intervention: GB261 (TCE-type bispecific antibody)

TCE Early Phase I

An Open-label Study of Cizutamig in Refractory Seropositive Rheumatoid Arthritis

Registration number: NCT06946199
Indication: Refractory seropositive rheumatoid arthritis
Intervention: Cizutamig (TCE-type bispecific antibody)

in vivo CART Exploratory clinical study

Clinical Study of EVM18001 in the Treatment of Refractory Autoimmune Diseases

Registration number: NCT07470151
Indication: Systemic lupus erythematosus, systemic sclerosis and myasthenia gravis
Intervention: EVM18001 injection

TCE IIT

Study of YKST02 Alone or in Combination With YK012 in Patients With Active or Refractory Systemic Lupus Erythematosus

Registration number: NCT07512947
Indication: Refractory or active systemic lupus erythematosus
Intervention: YKST02 (CD3×CD19)

TCE Phase Ib

A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Preliminary Efficacy, Pharmacokinetics, and Immunogenicity of F182112 in Patients with Systemic Lupus Erythematosus

Registration number: CTR20253359
Indication: Systemic lupus erythematosus
Intervention: F182112 (recombinant humanized anti-BCMA/CD3 bispecific T-cell engager)

TCE Phase I

A Dose-Escalation Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-1045 in Participants with Systemic Lupus Erythematosus or Rheumatoid Arthritis

Registration number: CTR20260744
Indication: Systemic lupus erythematosus and rheumatoid arthritis
Intervention: MK-1045 (bispecific T-cell engager targeting CD3×CD19)

TCE Phase I

An Open-Label, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 Following Single Ascending and Step-Up Doses in Adult Participants with Systemic Lupus Erythematosus or Idiopathic Inflammatory Myopathies

Registration number: CTR20252694
Indication: Systemic lupus erythematosus and idiopathic inflammatory myopathies
Intervention: AZD5492 (targeting CD20, CD8 and the T-cell receptor)

TCE Phase Ib/IIa

A Study of GR1803 in Systemic Lupus Erythematosus

Registration number: NCT07348055
Indication: Systemic lupus erythematosus and idiopathic inflammatory myopathies
Intervention: GR1803 injection (CD3 and BCMA)