NCT07015983进行中（未招募）2 期
A Phase 2, Multicenter, Open-Label Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE (Including Lupus Nephritis) With Inadequate Response to Glucocorticoids and at Least 2 Immunosuppressants (Breakfree-SLE)
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company238 个研究点 分布在 11 个国家目标入组 89 人开始时间: 2025年7月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 89
- 试验地点
- 238
- 主要终点
- Proportion of participants achieving drug-free Definition of Remission in Systemic Lupus Erythematosus (DORIS) remission
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety and drug levels of CC-97540 in participants with active systemic lupus erythematosus (SLE) including lupus nephritis with inadequate response to glucocorticoids and at least 2 immunosuppressants.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet EULAR/ACR 2019 criteria for SLE.
- •Participants must have an inadequate response to appropriate doses of glucocorticoids and ≥ 2 immunosuppressant therapies, used for at least 3 months.
- •Participants must have active disease when signing ICF.
排除标准
- •Participants must not have other diseases, conditions, or treatments that may confound interpretation of the effects of CC-97540 in SLE.
- •Uncontrolled or clinically significant cardiovascular conditions or CNS pathology participants must not have prior history of malignancies or lymphoproliferative disease, unless the participant has been free of the disease for ≥ 2 years, except for some non-invasive malignancies.
- •IOCBP who are pregnant, nursing, or breastfeeding, or who intend to become pregnant.
- •Participants must not have prior treatment with CAR T cell therapy, genetically modified T cell therapy, stem cell transplant or organ transplant.
- •Participants must not have received live vaccines within 6 weeks before LDC (lymphodepleting chemotherapy) administration.
- •Participant must not have inadequate organ function.
- •Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Administration of CC-97540
Experimental
干预措施: CC-97540 (Drug)
Administration of CC-97540
Experimental
干预措施: Cyclophosphamide (Drug)
Administration of CC-97540
Experimental
干预措施: Fludarabine (Drug)
结局指标
主要结局
Proportion of participants achieving drug-free Definition of Remission in Systemic Lupus Erythematosus (DORIS) remission
时间窗: At month 6
次要结局
- Complete renal response (CRR) for participants with baseline lupus nephritis (LN)(Up to Month 60)
- Participants with drug-free DORIS remission(Up to month 60)
- CRR for participants with baseline LN(Up to month 60)
- Modified CRR for participants with baseline LN(Up to month 60)
- Number of participants achieving Lupus Low Disease Activity State (LLDAS) with baseline Systemic Lupus Erythematosus Disease Activity Questionnaire (SLEDAI) ≥6(Up to month 60)
- Number of participants achieving SLE Responder Index (SRI) - 4 with baseline SLEDAI ≥6(Up to month 60)
- Number of participants with flares as assessed by SLEDAI flare index(Up to month 60)
- Severity of participants with flares as assessed by SLEDAI flare index(Up to month 60)
- Change from baseline in proteinuria(Up to month 60)
- Change from baseline in estimated glomerular filtration rate (eGFR)(Up to month 60)
- Percentage of participants achieving maintenance of drug-free DORIS remission(Up to month 60)
- Percentage of participants achieving maintenance of LLDAS(Up to month 60)
- Percentage of participants achieving maintenance of SRI-4(Up to month 60)
- Time from first response to loss of response for drug-free DORIS remission(Up to month 60)
- Time from first response to loss of response for LLDAS(Up to month 60)
- Time from first response to loss of response for SRI-4(Up to month 60)
- Time from baseline to first drug-free DORIS remission(Up to month 60)
- Time from baseline to LLDAS(Up to month 60)
- Time from baseline to SRI-4(Up to month 60)
- Duration of drug-free status(Up to month 60)
- Percentage of participants achieving DORIS remission regardless of drug-free status(Up to month 60)
- Glucocorticoid used post-infusion for SLE treatment(Up to month 60)
- Change of serum autoantibodies from baseline(Up to month 60)
- Change in complement factor (C3 and C4) levels from baseline(Up to month 60)
- Change from baseline in patient reported outcomes (PRO) as assessed by FACIT-Fatigue(Up to month 60)
- Change from baseline in PRO as assessed by SF 36 v2 Acute(Up to month 60)
- Change from baseline in PRO as assessed by EQ-5D-5L(Up to month 60)
- Change from baseline in PRO as assessed by Patient Global Impression of Severity (PGI-S) Pain(Up to month 60)
- Change from baseline in PRO as assessed by PGI-S Fatigue(Up to month 60)
- Patient Global Impression of Change (PGI-C) Pain(Up to month 60)
- PGI-C Fatigue(Up to month 60)
- Change from baseline in Systemic Lupus International Collaborating Clinics (SLICC)/ACR (American College of Rheumatology) damage index(Up to month 60)
- Number of participants with Adverse Events (AEs)(Up to month 60)
- Number of participants with serious AEs (SAEs)(Up to month 60)
- Number of participants with AESIs (AEs of Special Interest)(Up to month 60)
- Number of participants with clinically significant laboratory abnormalities(Up to month 60)
研究者
研究点 (238)
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