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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
KSVCBD injection
DrugKSVCBD injection is an in vivo CAR-T therapy targeting CD19/BCMA and is administered by IV infusion.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Autoimmune DiseasesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose limited toxicity (DLT)
DLT is defined as any of the following adverse events (AEs) related to KSVCBD infusion occurring within 28 days after KSVCBD infusion (CRS and ICANS will be graded according to the ASTCT 2019 criteria, and other AEs will be evaluated using CTCAE v6.0).
Time frame
Within 28 days post-infusion2
Adverse events (AEs) and serious adverse events (SAEs)
Incidence and severity of AEs and SAEs
Time frame
Within 24 months post-infusion3
Adverse events of special interest (AESI)
Incidence and severity of AESIs.AESI including grade ≥3 Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), and infections.
Time frame
Within 24 months post-infusion.4
Recommended Phase 2 Dose (RP2D)
Time frame
Within 24 months post-infusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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