Injection of GNC-038 antibody for rheumatoid arthritis treatment

A Randomized Controlled Phase l Clinical Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics/Pharmacodynamics of GNC-038 Tetra-specific Antibody Injection in Rheumatoid Arthritis

This study is testing a new antibody treatment for people with moderate to severe rheumatoid arthritis to see if it helps them feel better while they continue their usual care.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: CAR-T
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06857227 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety, efficacy, and pharmacokinetic/pharmacodynamic characteristics of GNC-038, a tetra-specific antibody, in patients with rheumatoid arthritis. It consists of two phases: a phase Ia single-arm study followed by a phase Ib randomized controlled study with a placebo group. The trial aims to assess the treatment's impact on patients diagnosed with moderately to severely active rheumatoid arthritis while maintaining a stable standard-of-care regimen. Participants will be monitored for their response to the treatment and any potential side effects.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with a diagnosis of moderately to severely active rheumatoid arthritis.

Not a fit: Patients with mild rheumatoid arthritis or those who have not been on a stable standard-of-care regimen may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from rheumatoid arthritis.

How similar studies have performed: Other studies involving similar antibody treatments for rheumatoid arthritis have shown promising results, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Subjects can understand the informed consent form, voluntarily participate in and sign the informed consent form;
2. No gender limit;
3. Age: ≥18 years old and ≤75 years old;
4. Life expectancy greater than 6 months;
5. Patients diagnosed with rheumatoid arthritis according to 1987 or 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria;
6. Patients were moderately to severely active RA at the time of screening;
7. A stable standard-of-care regimen was maintained for at least 30 days before the first dose;
8. Previous treatment with antirheumatic drugs other than MTX: Leflunomide should be discontinued at least 8 weeks before the start of study treatment or cholestyramine should be used for 14 days;
9. Erythrocyte sedimentation rate (ESR) \> 28mm/hr or C-reactive protein (CRP) \> 10mg/L;
10. Positive rheumatoid factor and/or anti-cyclic citrullinated peptide antibodies;
11. There were CD19+ B cells in the peripheral blood of the patient;
12. Diagnosis of rheumatoid arthritis (RA) more than 6 months;
13. The organ function level before the first administration met the requirements;
14. Fertile female subjects or male subjects with fertile partners must use highly effective contraception from 7 days before the first dose until 24 weeks after the termination of treatment and should commit not to donate eggs (eggs, oocytes)/sperm for assisted reproduction for 1 year after the last study treatment. Female subjects of childbearing potential must have a negative serum/urine pregnancy test within 7 days before the first dose;
15. Participants were able and willing to comply with protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures.

Exclusion Criteria:

1. Confirmed diagnosis of another autoimmune rheumatic disease;
2. B cell-targeted therapy agents administered within 6 months before GNC-038 treatment;
3. Received CAR-T therapy within 6 months before GNC-038 treatment;
4. Use of anti-TNF drugs within 8 weeks before administration;
5. Use of any JAK inhibitor within 2 weeks before dosing;
6. Antimalarial drugs, sulfasalazine, penicillamine, etc. were used within 4 weeks before the drug administration;
7. Use of phytochemicals within 4 weeks before administration;
8. The use of other biological agents or other non-B cell depleting clinical investigational drugs before drug administration did not exceed 5 half-lives;
9. Received an intra-articular injection within 4 weeks before study entry;
10. Receipt of any investigational drug within 28 days before dose or within 5 half-lives of the investigational drug;
11. ACR functional class IV or bedridden/wheelchair-bound;
12. History of major organ transplantation or hematopoietic stem cell/bone marrow transplantation;
13. Presence of: 1) active hepatitis B at screening; 2) hepatitis C or HIV infection; 3) syphilis infection;
14. A history of any cardiovascular disease described in the protocol within 6 months before screening;
15. Poorly controlled hypertension (systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg);
16. Prolonged QT interval at rest (QTcf \> 450 msec in men or \> 470 msec in women);
17. A history of ≥ grade 2 bleeding within 30 days before screening or the need for long-term continuous anticoagulant therapy;
18. Patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of GNC-038;
19. Women who are pregnant or breastfeeding;
20. Having a history or evidence of suicidal thoughts within 6 months before signing ICF, which is considered by the researcher to be a significant risk of suicide;
21. Diagnosed with malignant tumor within 5 years before signing ICF;
22. Other situations of poor compliance, unwillingness or inability to comply with the study protocol as judged by the investigator;
23. History of splenectomy;
24. Investigators considered a history of alcohol or drug abuse in the 12 months before screening;
25. Any active infection requiring systemic antibiotic treatment within 2 weeks before or during screening;
26. A history of severe and/or disseminated viral infection;
27. Active M. tuberculosis infection may be present.

Where this trial is running

Shanghai, Shanghai Municipality

• Renji Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Sa Xiao, PHD

Conditions Rheumatoid Arthritis