Safety and Efficacy of KSVCBD Injection in Autoimmune Diseases
ConditionAutoimmune Diseases
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorChinese PLA General Hospital
About this trial
KSVCBD injection is an in vivo Chimeric Antigen Receptor T-Cell (CAR-T cell) therapy product. This single-arm, open-label, early exploratory clinical study is designed to evaluate the safety and preliminary efficacy of KSVCBD injection in patients with Autoimmune Diseases.
Eligibility criteria
Qualifiers
Age 18-65 years (inclusive), any gender.
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.
Voluntarily adhere to the contraception requirements as specified in the protocol.
Willing to comply with all study procedures and voluntarily participate in this study and sign the informed consent form (ICF).
Disqualifiers
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.
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.
Use of any of the protocol specified drugs or treatments within the specified timeframes.
History or current symptoms of severe central nervous system (CNS) disease within the past 6 months.
Trial design
Treatments tested in this trial
- KSVCBD injection
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov