Safety and Efficacy of KSVCBD Injection in Autoimmune Diseases

Официальное название

A Clinical Study to Evaluate the Safety and Efficacy of KSVCBD Injection in Patients With Autoimmune Diseases

Обзор

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.

Подробное описание

KSVCBD-R102 is an open-label study in subjects with autoimmune diseases and will be conducted in two stages: dose escalation (Stage A) and dose expansion (Stage B). In Stage A, a total of three dose levels explored. At the recommended dose established during the dose-escalation phase, subjects will be enrolled in a dose-expansion study to further evaluate the safety and preliminary efficacy of KSVCBD injection in subjects with autoimmune diseases. The dose-expansion study will explore two separate cohorts, each enrolling subject with an indication for which preliminary efficacy data have been obtained during the dose-escalation phase.

Вмешательства

• Препарат KSVCBD injection
  KSVCBD injection is an in vivo CAR-T therapy targeting CD19/BCMA and is administered by IV infusion.

Первичные конечные точки

• Dose limited toxicity (DLT) [Срок оценки: Within 28 days post-infusion]
• Adverse events (AEs) and serious adverse events (SAEs) [Срок оценки: Within 24 months post-infusion]
• Adverse events of special interest (AESI) [Срок оценки: Within 24 months post-infusion.]
• Recommended Phase 2 Dose (RP2D) [Срок оценки: Within 24 months post-infusion]

Критерии участия

Критерии включения

• 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.
• Having adequate organ function as required by the protocol.:
• 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).

Критерии исключения

• 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.
• Known severe allergy to the study drug or any of its components.
• Presence of uncontrolled fungal, bacterial, or viral infection, or other infections considered by the investigator to make the subject unsuitable for participation.
• History of major organ transplant or hematopoietic stem cell/bone marrow transplantation.
• History of other autoimmune diseases requiring systemic treatment, other than the target indication.
• History of non-IIM conditions such as drug induced myopathy, HIV associated myopathy, thyroid myopathy, or family history of myopathy.
• Pregnant or breastfeeding women.
• Use of any live vaccines within 6 weeks before enrollment.
• 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.
• Psychiatric disorders with depression or suicidal tendencies.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Chinese PLA General Hospital — Пекин

Идентификаторы

NCT: NCT07613411 · KSVCBD-R102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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