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New treatment option for Rheumatoid Arthritis
Official title A Study of GNC-038 Tetra-specific Antibody Injection in Patients With Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT06857227
What this study is testing
What is GNC-038?
GNC-038 is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for rheumatoid arthritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a randomized controlled phase I clinical study with safety, efficacy, and pharmacokinetic/pharmacodynamic characteristics in patients with rheumatoid arthritis.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- people can understand the informed consent form, voluntarily participate in and sign the informed consent form;
- No gender limit;
- Age: ≥18 years old and ≤75 years old;
- Life expectancy greater than 6 months;
- Patients diagnosed with rheumatoid arthritis according to 1987 or 2010 American College of Rheumatology (ACR)/European League Against Rheumatism...
You likely can't join if
- Confirmed diagnosis of another autoimmune rheumatic disease;
- B cell-targeted therapy agents administered within 6 months before GNC-038 treatment;
- Received CAR-T therapy within 6 months before GNC-038 treatment;
- Use of anti-TNF drugs within 8 weeks before administration;
- Use of any JAK inhibitor within 2 weeks before dosing;
- Antimalarial drugs, sulfasalazine, penicillamine, etc. were used within 4 weeks before the drug administration;
See the full eligibility criteria
- people can understand the informed consent form, voluntarily participate in and sign the informed consent form;
- No gender limit;
- Age: ≥18 years old and ≤75 years old;
- Life expectancy greater than 6 months;
- Patients diagnosed with rheumatoid arthritis according to 1987 or 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria;
- Patients were moderately to severely active RA at the time of screening;
- A stable standard-of-care regimen was maintained for at least 30 days before the first dose;
- 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;
- Erythrocyte sedimentation rate (ESR) \> 28mm/hr or C-reactive protein (CRP) \> 10mg/L;
- Positive rheumatoid factor and/or anti-cyclic citrullinated peptide antibodies;
- There were CD19+ B cells in the peripheral blood of the patient;
- Diagnosis of rheumatoid arthritis (RA) more than 6 months;
- The organ function level before the first administration met the requirements;
- Fertile female people or male people 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...
- Participants were able and willing to comply with protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures.
- Confirmed diagnosis of another autoimmune rheumatic disease;
- B cell-targeted therapy agents administered within 6 months before GNC-038 treatment;
- Received CAR-T therapy within 6 months before GNC-038 treatment;
- Use of anti-TNF drugs within 8 weeks before administration;
- Use of any JAK inhibitor within 2 weeks before dosing;
- Antimalarial drugs, sulfasalazine, penicillamine, etc. were used within 4 weeks before the drug administration;
- Use of phytochemicals within 4 weeks before administration;
- The use of other biological agents or other non-B cell depleting clinical investigational drugs before drug administration did not exceed 5 half-lives;
- Received an intra-articular injection within 4 weeks before study entry;
- Receipt of any investigational drug within 28 days before dose or within 5 half-lives of the investigational drug;
- ACR functional class IV or bedridden/wheelchair-bound;
- History of major organ transplantation or hematopoietic stem cell/bone marrow transplantation;
- Presence of: 1) active hepatitis B at screening; 2) hepatitis C or HIV infection; 3) syphilis infection;
- A history of any cardiovascular disease described in the protocol within 6 months before screening;
- Poorly controlled hypertension (systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg);
- Prolonged QT interval at rest (QTcf \> 450 msec in men or \> 470 msec in women);
- A history of ≥ grade 2 bleeding within 30 days before screening or the need for long-term continuous anticoagulant therapy;
- Patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of GNC-038;
- Women who are pregnant or breastfeeding;
- 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;
- Diagnosed with malignant tumor within 5 years before signing ICF;
- Other situations of poor compliance, unwillingness or inability to comply with the study protocol as judged by the investigator;
- History of splenectomy;
- Investigators considered a history of alcohol or drug abuse in the 12 months before screening;
- Any active infection requiring systemic antibiotic treatment within 2 weeks before or during screening;
- A history of severe and/or disseminated viral infection;
- Active M. tuberculosis infection may be present.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.