NCT06182696招募中1 期
An Open Label,Multi-center Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Autologous T Cell Injection Targeting GPRC5D OriCAR-017 in Patients With Relapsed and/or Refractory Multiplemyeloma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 83
- 试验地点
- 5
- 主要终点
- Maximum tolerated dose of OriCAR-017-P1
研究概览
简要总结
An open label, dose exploratory clinical study to evaluate the safety, efficacy, and pharmacokinetics of OriCAR-017 in R/RMM
详细描述
This is a Phase I and Phase II, open-label, multi-center study to assess the safety, pharmacokinetics, and efficacy of GPRC5D directed chimeric antigen receptor modified T cells injection (OriCAR-017) in n patients with relapsed and/or refractory multiplemyeloma (R/RMM).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of R/RMM according to the IMWG criteria;
- •Expected survival period is >12 weeks;
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 or 2 at the time of ICF signature;
- •The expression of GPRC5D in bone marrow plasma cells membrane is more than 20% by flow cytometry and/or immunohistochemistry, multiple myeloma with measurable lesions, and at least one of the following criteria must be met:
- •Serum M protein >5 g/L;
- •Urine M protein level >200 mg/24 hour;
- •Serum free light chain (sFLC) >100 mg/L and K/λ FLC ratio is abnormal;
- •Primitive immature or monoclonal plasma cells >5% by bone marrow cytology or flow cytometry.
- •Subjects who had received at least 3 prior lines of therapy including (but not limited to) immunomodulatory drugs (IMiDs), proteasome inhibitors, anti-CD38 monoclonal antibodies, etc., but have failed treatment, including those who have experienced relapse (within 12 months), refractory or intolerant to the last line treatment regimen.
排除标准
- •Smoldering myeloma (asymptomatic)
- •Multiple myeloma with only extramedullary lesions;
- •Plasma cell leukemia;
- •Concurrent amyloidosis;
- •Central nervous system metastasis, leptomeningeal disease or metastatic central compression;
- •HBsAg or HbcAb is positive, and the quantitative detection of hepatitis B virus (HBV) DNA in peripheral blood is more than 100 copies/L; hepatitis C virus (HCV) antibody and HCV RNA in peripheral blood is positive; human immunodeficiency virus (HIV) antibody positive; syphilis antibody is positive at Screening; Cytomegalovirus DNA test is positive;
- •Had hypersensitivity or intolerance to any drug/excipient (including conditioning chemotherapy) used in this study;
- •Previously received treatment targeting GPRC5D, including but not limited to antibodies, ADC, or CAR-T;
- •Subjects who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks of Screening Visit or who plan to undergo ASCT during the study;
- •Any uncontrolled active infection within 4 weeks prior to ICF signing or leukapheresis requires parenteral antibiotic, antiviral, or antifungal treatment
- •Major surgery within 28 days prior to Screening Visit with the exception of a biopsy and an insertion of a central venous catheter or during the study;
- •Subjects who received allogeneic stem cell therapy;
- •Subjects complications or other conditions evaluated by investigators may affect compliance with the protocol or make them unsuitable to participate in this study;
- •Pregnant or breastfeeding.
结局指标
主要结局
Maximum tolerated dose of OriCAR-017-P1
时间窗: Up to 28 days
The MTD is defined as the highest dose with an observed incidence of DLT in no more than one out of six patients treated at a particular dose level.
Dose-limiting toxicity (DLT)
时间窗: Up to 28 days
tolerability
次要结局
- Objective Response Rate(From date of randomization until the date of first documented progression or date of death from any cause or withdraw, whichever came first, assessed up to 2 Years)
- Antitumor efficacy-Duration of response (DOR)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years)
- Pharmacokinetics (the number of cell copies and cell persistence duration in peripheral blood)(From date of randomization until the date of first documented progression or date of death from any cause or withdraw, whichever came first, assessed up to 2 years)
- Long term survival follow up(From date of randomization until the date of first documented date of death from any cause, assessed up to 15 years)
- Antitumor efficacy-Progression-free survival (PFS)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years)
研究者
研究点 (5)
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