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Tests treatment safety and results for Systemic Lupus Erythematosus
Official title Efficacy and Safety of HN2301 in Autoimmune Diseases（AIDs）
ClinicalTrials.gov ID: NCT06801119
What this study is testing
What is HN2301 injection?
HN2301 injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for systemic lupus erythematosus.
Also referred to as in vivo cart.
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 is an open lable and single arm study, is designed to evaluate the safety and preliminary efficacy of HN2301 in Autoimmune Disease（AID）
- Phase 1: an early, usually small safety study
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 69
You may be able to join if
- Patients aged between 18 and 69 (inclusive), of any gender;
- Appropriate bone marrow, coagulation, cardiopulmonary, liver, and kidney functions. Bone marrow function: ANC ≥1.5×10\^9/L, ALC ≥0.8×10\^9/L, Hb...
- Non-pregnant/non-lactating participants, willing to adopt contraceptive measures within 12 months after drug infusion;
- Diagnosed with SLE according to the 2019 EULAR/ACR SLE diagnostic criteria; A history of SLE for at least 6 months, having used a stable standard...
- SSc-meets the classification criteria of ACR and EULAR, 10-35 in mRSS score;
You likely can't join if
- Individuals with positive Hepatitis B surface antigen (HBsAg) and/or Hepatitis B core antibody (HBcAb), and Hepatitis B virus (HBV) DNA positivity or...
- Presence of other uncontrolled active infections;
- History of major organ transplantation (such as heart, lung, liver, kidney) or bone marrow/hematopoietic stem cell transplantation;
- Pregnant or breastfeeding women;
- Receiving any mRNA-LNP product or other LNP medications within the past two years;
- History of any of the following cardiovascular diseases within the last 6 months before screening: Class III or IV heart failure defined by the New...
See the full eligibility criteria
- Patients aged between 18 and 69 (inclusive), of any gender;
- Appropriate bone marrow, coagulation, cardiopulmonary, liver, and kidney functions. Bone marrow function: ANC ≥1.5×10\^9/L, ALC ≥0.8×10\^9/L, Hb ≥80g/L. No use of transfusions and growth factors allowed within 7 days...
- Non-pregnant/non-lactating participants, willing to adopt contraceptive measures within 12 months after drug infusion;
- Diagnosed with SLE according to the 2019 EULAR/ACR SLE diagnostic criteria; A history of SLE for at least 6 months, having used a stable standard treatment regimen for at least 8 weeks; Oral corticosteroids are...
- SSc-meets the classification criteria of ACR and EULAR, 10-35 in mRSS score;
- RA-meets the classification criteria of ACR and EULAR, DAS28-ESR\>3.2, ACPA possitive.
- Individuals with positive Hepatitis B surface antigen (HBsAg) and/or Hepatitis B core antibody (HBcAb), and Hepatitis B virus (HBV) DNA positivity or titers above the detection threshold; those with positive Hepatitis C...
- Presence of other uncontrolled active infections;
- History of major organ transplantation (such as heart, lung, liver, kidney) or bone marrow/hematopoietic stem cell transplantation;
- Pregnant or breastfeeding women;
- Receiving any mRNA-LNP product or other LNP medications within the past two years;
- History of any of the following cardiovascular diseases within the last 6 months before screening: Class III or IV heart failure defined by the New York Heart Association (NYHA), myocardial infarction, unstable angina...
- History of live vaccine administration within the last 30 days;
- Individuals with asthma, severe allergies;
- Other conditions deemed inappropriate for participation in this clinical study by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, 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 69 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, 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.