A Phase1 Open Label Study of the Safety and Pharmacokinetics of SM03, an anti-CD22 antibody, in Chinese Systemic Lupus Erythematosus Subjects With Active Disease

Status

Active, not recruiting

Phases

Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-OIN-15007541

Enrollment

Unknown

Registered

2015-12-08

Start date

2011-12-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus

Interventions

Group1, 240mg/m2:240 mg/m2 infusions weekly for 4 doses

Group2, 600 mg:600 mg infusion weekly for 4 doses

Group3, 900 mg:900 mg infusion weekly for 4 doses

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Current clinical diagnosis of Systemic Lupus Erythematosus by American College of Rheumatology (ACR) criteria; 2. 18-65 years old,both gender; 3. over six months with SLE;

Exclusion criteria

Exclusion criteria: 1. Subjects with active SLE disease involved CNS; 2. Subjects with active SLE disease involved renal system; 3. Subjects with chronic infections, or risk of new infections; 4. History of hypersensitivity to murine antibody; 5. Histroy of maliganecy.

Design outcomes

Primary

Measure	Time frame
AUC, Cmax, T1/2;	—

Secondary

Measure	Time frame
BILAG score;SLEDAI score;	—

Countries

China

Contacts

Public ContactJi Jiang

pk.frosh@gmail.com+86 010-6915 8357

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026