Safety and Efficacy on Deoxyspergualin (NKT-01) in Patients With Lupus Nephritis

• SELENA-SLEDAI score [ Time Frame: The last day of the 4th, 6th and 9th cycle ] [ Designated as safety issue: No ]
• Treatment days of corticosteroids <= 7.5 mg/day [ Time Frame: Throughout study period ] [ Designated as safety issue: No ]
• Leucopenia (>= grade 3), Infection, Other adverse events [ Time Frame: Throughout study period ] [ Designated as safety issue: Yes ]

The aim of the open multi-center study is to determine an efficient and safe dose and dosing schedule of NKT-01 in induction of response in treatment of lupus nephritis.

The purpose of this phase I/II study ia to establish that dose of NKT-01 which leads to complete response during a minimum of 6 cycles of treatment without causing WHO grade 3 leukopenia (WBC < 2x10^9/L). The patients suffered from uncontrolled lupus nephritis (LN) and took OCS (<= 1.0 mf/kf/day, a maximum dose of 80 mg/day) in addition to NKT-01. Therefore the aim of the open multi-center study is to determine an efficient and safe dose and dosing schedule of NKT-01 in induction of response in treatment of lupus nephritis.

Inclusion Criteria:

• Males and females aged 18-70 years.
• A diagnosis of SLE according to the ACR criteria (at least 4/11 criteria).
• Sufficient signs to diagnose active SLE nephritis.
• Serum creatinine concentration of <= 5.0 mg/dL.
• Leucocyte counts >= 4000/uL.
• Receiving OCS (<= 1.0 mg/kg/day; a maximum dose of 80 mg/day).
• Prior treatment with cyclophosphamide, azathioprine, cyclosporin A, or any other immunosuppressive drugs.

Exclusion Criteria:

• Chronic infection of HIV, Hepatitis B, Hepatitis C.
• Acute infection including fungal, viral, bacterial or protozoal diseases.
• Liver toxicity (WHO CTC class 2 and higher). No adequate liver function (total bilirubin > 25 umol/L = 1.4 mg/dL unless explained otherwise (e.g. inherited, hemolysis), SGOT > 2.5 x N, SGPT > 2.5 x N).
• Pregnant or lactating women
• Female patients of child bearing age without safe method of contraception.
• Anemia (hemoglobin < 8.0 g/dL), leucopenia (leucocytes < 4000/uL unless attributable to SLE: leucocytes < 2000/uL), thrombocytopenia (platelets < 50000/uL).
• Neutrophils below 1000/uL.
• Hypogammaglobulinemia below 400 mg/dL of serum IgG.
• Any other condition that in the eyes of the investigator might have rendered the patient unsuitable for participation in the study. This especially includes major and active SLE organ involvement other than the kidney. Patients with SLE involvement of the central nervous system are not allowed to be included into the study.
• History of malignancy.
• Current participation in another trial or lass than 6 months since participation in a similar trial.