NCT05765006招募中1 期
A Phase I Dose-escalation Study Evaluate the Safety Tolerability Pharmacokinetics(PK) and Pharmacodynamics(PD) of Relma-cel in Subjects With Moderate to Severe Active Systemic Lupus Erythematosus (SLE)
Shanghai Ming Ju Biotechnology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年2月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- determine RP2D
研究概览
简要总结
This is a phase I, open-label, single-arm, multicenter study to asess the safety tolerability pharmacokinetics and pharmacodynamics of Relma-cel in moderate or severe active systemic lupus erythematosus (SLE) subjects in China.
详细描述
This is a phase I, open-label, single-arm, multicenter study to asess the safety tolerability pharmacokinetics(PK) and pharmacodynamics(PD) of Relma-cel in moderate or severe active systemic lupus erythematosus (SLE) subjects in China.
There will be 4 dose level (15x106 CAR+ T cells as the back up dose ,25x106 CAR+ T cells as the starting dose 、50x106 CAR+ T cells and 100x106(or 150 x106CAR+ T cells）Dose escalation, to evaluate the safety、 tolerability of Relma-cel in adult subjects of SLE and determine RP2D .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign an informed consent form (ICF) voluntarily.
- •At the time of signing the ICF, you must be between 18 and 70 years old (inclusive), male or female.
- •A diagnosis of SLE according to the 1997 revised criteria of the American College of Rheumatology (ACR).
- •The history of SLE prior to screening was at least 6 months, and the disease remained active at least 2 months after the use of a stable standard SLE regimen prior to screening.
- •Standard treatment regimen refers to the steady use of any of the following (alone or in combination) : corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and other immunosuppressants or immunomodulators including azathioprine, Mycophenolate Mofetil, cyclophosphamide, methotrexate, leflunomide, tacrolimus, and cyclosporine.
- •Oral corticosteroids must meet the following requirements:
- •Prednisone (or equivalent) ≥7.5 mg/ day, and ≤30 mg/ day.
- •There is no minimum daily dose requirement for corticosteroids when used in combination with immunosuppressants.
- •At least 8 weeks of treatment prior to screening, and the dose must be kept stable for > 2 weeks.
- •Screening is positive for antinuclear antibodies, and/or anti-DS-DNA antibodies, and/or anti-Smith antibodies.
- •SELENA-SLEDAI score ≥8 during the screening period. Score ≥6 for SELENA-SLEDAI clinical symptoms (except for low complement and/or anti-DS-DNA antibodies) if low complement and/or anti-DS-DNA antibody score is present.
排除标准
- •Severe lupus nephritis (defined as proteinuria > 6 g/24h or serum creatinine > 2.5 mg/dL or 221 μmol/L), treatment with active nephritis with Prohibited drugs, hemodialysis, or prednisone ≥100 within 8 weeks prior to screening mg/d or equivalent glucocorticoid therapy ≥14 days.
- •Prior to screening, other lupus crises, such as active central nervous system lupus, severe hemolytic anemia, severe thrombocytopenic purpura, severe agranulocytosis, severe myocardial damage, severe lupus pneumonia or pulmonary hemorrhage, severe lupus hepatitis, and severe vasculitis.
- •Clinically significant central nervous system diseases or pathological changes not caused by lupus prior to screening, including but not limited to: cerebrovascular accident, aneurysm, epilepsy, convulsions/convulsions, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
- •Combined with other autoimmune diseases, systematic treatment is needed.
- •History of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation.
- •IgA deficiency was present during screening (serum IgA level < 10 mg/dL)
结局指标
主要结局
determine RP2D
时间窗: 3 months
To determine RP2D(Phase 2 recommended dose)
DLT rate
时间窗: 3 months
The incidence of dose-limiting toxicity
次要结局
- SELENA-SLEDAI （Safety of Estrogens in Systemic Lupus Erythematosus National Assessment） score； 0 to 4 is basically no disease activity; 5 to 9 is light activity; 10 to 14 is moderate activity;≥15 is considered heavy activity.(3 months)
- BILAG -2004（updated version of british isles lupus assessment group ） level；The BILAG 2004 index categorizes disease activity into 5 different levels from A-E.Grade A represents very active disease.(3 months)
- PGA (physician global assessment) score,The PGA scale ranges from "no disease activity" (0) to the "most severe disease activity" (3).the score is between 0 to 3.(3 months)
- Autoantibody detection(3 months)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
1 期
MAX-10181 in Patients With Advanced Solid TumorSolid TumorNCT05196360Maxinovel Pty., Ltd.80
招募中
1 期
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BPI-21668Advanced Solid TumorNCT05341570Betta Pharmaceuticals Co., Ltd.60
招募中
1 期
A Study of BPI-460372 in Advanced Solid Tumor PatientsAdvanced Solid TumorNCT05789602Betta Pharmaceuticals Co., Ltd.82
招募中
1 期
A Study of SYH2051 Monotherapy in Advanced Solid Tumors or in Combination With Radiotherapy in Locally Advanced Head and Neck CancerSolid TumorsHead and Neck CancerNCT06011291CSPC ZhongQi Pharmaceutical Technology Co., Ltd.73
尚未招募
1 期
A Study of KQ-2003 CAR-T Cell Therapy for Patients With Relapsed or Refractory POEMS SyndromePOEMS SyndromeNCT06518876Novatim Immune Therapeutics (Zhejiang) Co., Ltd.21