MSC303 Subcutaneous Injection for the Treatment of Immunologic Glomerular Disease.

Naval Military Medical University (Second Military Medical University)

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: ANCA-Associated Glomerulonephritis; Lupus Nephritis (LN)

Treatments: Drug: Injection of MSC303

Study type: Interventional

Funder types: Other

Identifiers

NCT07000292

MSC303-CT201

Details and patient eligibility

About

This study will evaluate the safety and efficacy of MSC303 in patients with Immune glomerular diseases.

Full description

The primary endpoint of Phase Ib：Evaluate the safety of MSC303 in patients with Lupus Nephritis (LN）and ANCA-associated glomerulonephritis (ANCA-GN).

The primary endpoint of Phase II：Evaluate the change of Urine Protein/Creatinine Ratio (UPCR) in Week 12 compared with the baseline of MSC303 in patients with Lupus Nephritis(LN） and ANCA-associated glomerulonephritis (ANCA-GN).

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 18 to 65 years (including boundary values), gender unspecified；

2. Willing to participate voluntarily in this clinical study and with good compliance；

3. Regarding the criteria for the study diseases, meet the diagnostic criteria for any of the following diseases:

   1. Diagnosed with lupus nephritis(LN);
   2. diagnosed with ANCA-associated glomerulonephritis (ANCA-GN);

4. Sufficient organ function;

Exclusion criteria

1. History of severe allergic reaction to humanized monoclonal antibodies, or known allergy to any component of MSC303；
2. Active infection requiring antibiotic treatment；
3. Concomitant with other serious diseases；
4. Patients with congenital immunoglobulin deficiency；
5. Infection with human immunodeficiency virus (Human immunodeficiency virus (HIV)), hepatitis B or hepatitis C (including HBsAg, HBcAb positive with abnormal Hepatitis B Virus DNA (HBV DNA) or Hepatitis C virus RNA (HCV RNA ));
6. Other exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

MSC303

Experimental group

Description:

MSC303 is an asymmetric trivalent bispecific antibody targeting both CD20 and CD3 (with a ratio of CD20:CD3 at 2:1). By binding to the CD20 antigen on the surface of B cells with one end and the CD3 on the surface of T cells with the other, MSC303 recruits activated T cells around B cells, thereby enhancing the killing effect on B cells.

Treatment:

Drug: Injection of MSC303