CHT105 for the Treatment of Refractory Lupus Nephritis (NCT07517536) | Clinical Trial Compass
By InvitationNot Applicable
CHT105 for the Treatment of Refractory Lupus Nephritis
China14 participantsStarted 2026-04-22
Plain-language summary
Systemic lupus erythematosus (SLE) is the most common systemic autoimmune disease in China. The kidneys are the organ most frequently affected in SLE and a major cause of mortality among SLE patients. Currently, cell-based therapy has emerged as an innovative treatment approach for SLE. CHT105 injection is an allogeneic chimeric antigen receptor T (CAR-T) cell product derived from healthy donors' T cells, which are transduced with a lentiviral vector encoding an anti-CD19/CD70 CAR. This engineered T-cell product effectively recognizes and eliminates immune cells expressing CD19 and/or CD70 antigens-including autoreactive T and B cells-and holds promise as a novel therapeutic option for patients with refractory lupus nephritis (LN).
This study is a clinical trial evaluating the safety and preliminary efficacy of CHT105 injection-a CD19/CD70-targeting allogeneic CAR-T cell product-in adult patients with relapsed or refractory LN. Eligible participants will first undergo lymphodepleting preconditioning. Following confirmation of eligibility per standard infusion criteria, participants will receive a single intravenous infusion of CHT105 on Day 0 (D0). After CHT105 infusion, participants will undergo a 52-week short-term follow-up and up to a 15-year long-term follow-up.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 18-65 years (inclusive), regardless of sex;
. Meets at least four of the 11 SLE classification criteria recommended by the American College of Rheumatology (ACR) in 1997; or fulfills the 2019 European League Against Rheumatism (EULAR)/ACR classification criteria for SLE;
. Diagnosed with active, biopsy-confirmed lupus nephritis (LN) class III or IV, with or without concurrent class V, according to the 2018 International Society of Nephrology (ISN)/Renal Pathology Society (RPS) classification; renal biopsy must have been performed within one year prior to screening or during the screening period;
. Urine protein-to-creatinine ratio (UPCR) ≥ 1.0 g/g, or 24-hour urine protein ≥ 1.0 g, with or without active urinary sediment featuring red blood cell casts;
. Moderate-to-severe disease activity, as indicated by a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 6;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is described as 'enrolling by invitation only' — can you tell me if I might be considered for an invitation, and what criteria are typically used to identify eligible patients for a study like this?
2Since the trial is listed as 'Phase NA' and is primarily measuring the safety of CHT105 rather than its effectiveness, what does that mean for how much is already known about whether this treatment actually works for lupus nephritis?
3My lupus nephritis has been described as refractory, meaning it hasn't responded well to standard treatments — before considering an investigational injection like CHT105, are there any other approved therapies we haven't tried yet that might be worth exploring first?
4Because this study's main focus is on safety, what kinds of side effects or risks would you want me to be aware of when thinking about whether an experimental injection like CHT105 is appropriate for my situation?
5If I were invited to participate and enrolled in this trial, how would it affect my current treatment plan, and how closely would my kidney function be monitored throughout the study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety of CHT105 Injection in Subjects with Refractory Lupus Nephritis
Timeframe: From enrollment to the end of treatment at 52 weeks
Trial details
NCT IDNCT07517536
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
. At least one British Isles Lupus Assessment Group (BILAG-2004) A-grade (severe) organ domain score, or two B-grade (moderate) organ domain scores, or a combination thereof;
. Positive expression of CD19 and CD70 on peripheral blood B cells, as confirmed by flow cytometry;
. Refractory disease is defined as either failure to respond after ≥6 months of conventional therapy or recurrence of disease activity following prior remission. Conventional therapy includes glucocorticoids ± antimalarials, combined or sequentially administered with one or more of the following immunosuppressants: azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, leflunomide, thalidomide, tripterygium wilfordii, tacrolimus, cyclosporine A, sirolimus, voclosporin, JAK inhibitors (including those targeting JAK1/2/3 and TYK2), and biologics such as, but not limited to, anti-CD20 monoclonal antibodies, belimumab, and telitacicept;
Exclusion criteria
. Individuals with a history of severe drug allergy or allergic constitution;
. Presence of, or suspicion of, uncontrolled fungal, bacterial, viral, or other infections requiring hospitalization or intravenous therapy within one month prior to baseline;
. Any of the following cardiovascular or cerebrovascular events within six months prior to screening: unstable angina requiring hospitalization, myocardial infarction, coronary artery bypass grafting, percutaneous coronary intervention (diagnostic coronary angiography is permitted), moderate-to-severe congestive heart failure (NYHA Class III or IV), atrial or ventricular arrhythmias requiring hospitalization (e.g., atrial fibrillation, ventricular tachycardia), implantation of a pacemaker or defibrillator, cerebrovascular accident (e.g., stroke), or planned coronary artery bypass surgery or vascular reconstruction during the trial;
. Participants with congenital immunoglobulin deficiency;
. History of malignancy within the past five years (except for basal cell carcinoma, localized cutaneous squamous cell carcinoma, cervical carcinoma in situ, or thyroid carcinoma, all of which must have been definitively cured for at least one year);
. Participants with end-stage renal failure;
. Active tuberculosis risk at screening, regardless of whether adequate treatment has been completed-including signs or symptoms of active tuberculosis as judged by the investigator at screening (e.g., fever, cough, night sweats, weight loss); or evidence of active pulmonary tuberculosis on chest imaging (e.g., chest X-ray or chest CT scan) performed at screening or at any time within six months prior to screening;
. Participants who are positive for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb), with peripheral blood HBV DNA levels exceeding the upper limit of quantification; participants who are positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; participants who are positive for human immunodeficiency virus (HIV) antibody; or participants with a positive syphilis test;