Experimental CAR-T injection aims to tame autoimmune diseases
NCT ID NCT07613411
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests an injection called KSVCBD, a type of CAR-T cell therapy, in 60 adults with severe autoimmune diseases like lupus and scleroderma. The goal is to see if it's safe and to get a first look at whether it might help control the disease. Participants receive a single IV infusion and are monitored for side effects and response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- KSVCBD injection (a type of CAR-T cell therapy given by IV infusion)
- What this could lead to
- If successful, this could point toward a new treatment option for people with severe autoimmune diseases that haven't responded to other therapies.
- What could go wrong
- This is a very early, small trial (60 people) focused on safety, so it's too soon to know if it works. There are risks like severe immune reactions and infections.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Jun 2026
An estimate. Start dates often move.
- Expected to finish
-
Mar 2029
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18-65 years (inclusive), any gender. 2. Subjects diagnosed with the following autoimmune disease: moderate/severe refractory Systemic Lupus Erythematosus, elapsed/refractory Systemic Sclerosis, relapsed/refractory ANCA-Associated Vasculitis, refractory Idiopathic Inflammatory Myopathy, active Sjögren's Syndrome, chronic/refractory Immune Thrombocytopenia, refractory Antiphospholipid Syndrome, relapsed/refractory pemphigus, relapsed/refractory IgG4-Related Disease. 3. Having adequate organ function as required by the protocol.: 4. Voluntarily adhere to the contraception requirements as specified in the protocol. 5. Willing to comply with all study procedures and voluntarily participate in this study and sign the informed consent form (ICF). Exclusion Criteria: 1. Previous or current active malignancy, including patients with cancer-associated polymyositis/dermatomyositis. Exceptions are cured or relapse-free for at least 3 years: cervical carcinoma in situ, non-invasive basal cell or squamous cell skin cancer, locally advanced prostate cancer after radical treatment, or ductal carcinoma in situ after radical surgery. 2. Severe pulmonary disease within the past 1 year, such as moderate/severe pulmonary arterial hypertension (pulmonary artery systolic pressure \>50 mmHg on echocardiography), requirement for oxygen therapy via reservoir mask or non-invasive/invasive ventilator support at screening. 3. Use of any of the protocol specified drugs or treatments within the specified timeframes. 4. History or current symptoms of severe central nervous system (CNS) disease within the past 6 months. 5. Known severe allergy to the study drug or any of its components. 6. Presence of uncontrolled fungal, bacterial, or viral infection, or other infections considered by the investigator to make the subject unsuitable for participation. 7. History of major organ transplant or hematopoietic stem cell/bone marrow transplantation. 8. History of other autoimmune diseases requiring systemic treatment, other than the target indication. 9. History of non-IIM conditions such as drug induced myopathy, HIV associated myopathy, thyroid myopathy, or family history of myopathy. 10. Pregnant or breastfeeding women. 11. Use of any live vaccines within 6 weeks before enrollment. 12. Participation in another interventional clinical study and receipt of an active investigational drug within 3 months prior to signing the ICF, or intention to participate in another clinical trial or receive treatment for autoimmune diseases outside the protocol during the entire study period. 13. Psychiatric disorders with depression or suicidal tendencies. 14. Any other factors considered by the investigator to make the subject unsuitable for enrollment or to affect the subject's participation or completion of the study.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for ANCA associated vasculitis are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Ear-Zapping device may quiet lupus pain and fatigue
- Can a weekly dipstick at home catch lupus kidney damage early?
- Inhaled xenon gas could reveal hidden lung vessel disease without catheter
- Investigational drug AMG 335 offered to adults with IgG4-Related disease
- Can a Blood-Cleaning device hit its plasma exchange targets?
- Can a common antiplatelet drug replace warfarin after APS-Related stroke?