NCT05128786终止1 期
A Phase I Trial to Assess Safety, Tolerability and Anti-tumor Activity of Autologous T Cell Modified Chimeric Antigen Receptor (CAR) (CCT301-38) in Patients With Relapsed or Refractory AXL Positive Sarcomas
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- DLT
研究概览
简要总结
This clinical study is to investigate the safety and tolerability of CCT301-38 CAR modified autologous T cells (CCT301-38) in subjects with relapsed or refractory AXL positive sarcomas
详细描述
This study is an open label, single-center Phase I dose escalation trial to assess the safety, tolerability, DLT and MTD of CCT301-38 cell therapy in patients with AXL positive relapsed or refractory sarcomas.
Subjects that meet inclusion criteria with positive AXL biopsy (IHC 1+ or greater in ≥50% tumor cells) will receive CCT301-38 according to the 3+3 dose escalation design.
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
- •Patients with willingness to be in the study and follow all study procedures, and capable of providing informed consent
- •Male or female aged 18-70 years;
- •Patients with unresectable, locally advanced or metastatic relapse/refractory sarcomas that have failed at least the front line standard treatment confirmed by histology or cytology;
- •At least one measurable lesion, i.e. the length of non-lymph node lesions examined according to CT cross-sectional scanning or magnetic resonance imaging (MRI), or the short diameter of the lymph node lesions is ≥15 mm according to RECIST 1.1, and the FDG PET signal from the measurable lesion is > 3 SUV;
- •Tumors with AXL positive (IHC 1+ or greater) in ≥50% of all tumor cells. A new biopsy is required if the sample is over one year.
- •ECOG Performance Status 0-1;
- •Expected survival greater than 12 weeks;
- •Adequate organ and hematopoietic system functions to meet the following requirements:
- •Hemoglobin (HGB) s 90 g/L, no blood transfusions within two weeks;
- •White blood cell (WBC) count≥2.5×109/L；
- •Absolute Neutrophil Count (ANC) ≥1.5×109/L;
- •Platelet (PLT) count ≥80×109/L;
- •Total bilirubin (TBIL) ≤3.0ng/dL or ≤5 ULN;
- •ALT and AST ≤5 ULN; for liver metastasis, ALT and AST ≤5 ULN
- •Creatinine (Cr) ≤1.5 x ULN; or creatinine removal rate (CrCl) ≥50 mL/min;
- •PT: INR < 1.7 or extended PT to normal value < 4s
- •Normal language, recognition and consciousness assessed by investigator during screening phase;
- •Capable of receiving treatment and follow-up, including treatment in the clinical center;
排除标准
- •Females with pregnancy or in lactation period;
- •Subjects with active hepatitis B, or active hepatitis C. Subjects with undetectable HBV DNA or HCV RNA after anti-virus treatment can be enrolled;
- •HIV positive;
- •Other active infections of clinical significance;
- •Subjects with the following previous or accompanying diseases:
- •Subjects diagnosed as severe autoimmune diseases that require long term (more than 2 months) treatment with systemic immunosuppressants (steroids), or diseases with immune-mediated symptoms, including ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus (SLE), and autoimmune vasculitis (e.g. Wegena granuloma);
- •Patients with previous diagnosis as motor neuron disease caused by autoimmunity;
- •Patients previously suffered from toxic epidermal necrolysis (TEN)
- •Patients with any mental illness, including dementia, mental changes, which may cause difficulties understanding the informed consent and related questionnaires;
- •Patients with serious uncontrollable diseases, which may interfere with the therapies in this study;
- •Patients with other active malignancies in the past 5 years excluding those with completely cured basal or squamous skin cancers, superficial bladder cancers or primary breast cancers without need of follow-up treatment;
- •Subjects receiving systemic steroids or steroid inhalants;
- •Patients who have received tumor immunotherapy (including monoclonal antibody against PD-1, PD-L1, PD-L2, CD137 or CTLA-4, or cell therapy) in the past 4 weeks;
- •Subjects allergic to immunotherapies or related drugs;
- •Patients with metastatic lesions in meninges or central nervous system, or clear evidence of central nervous system diseases with continuous significant symptoms in the last 6 months;
- •Patients with NYHA class II heart failure, or hypertension incontrollable by standard care, or medical history of myocarditis, or heart attack within a year;
- •Subjects who have received or are going to receive organ transplantation;
- •Patients with active bleeding;
- •Patients with incontrollable pleural or abdominal fluid that needs clinical treatment or intervention;
- •Patients as determined by the investigators to be inappropriate for the study.
研究组 & 干预措施
CCT301-38
Experimental
To determine the safety, tolerability, DLT and MTD of CCT301-38 cell therapy in patients with AXL-positive relapsed or refractory sarcomas.
干预措施: CCT301-38 (Biological)
结局指标
主要结局
DLT
时间窗: 28 days following infusion
To assess the safety and tolerability of CCT301-38 cell therapy for patients with AXL-positive (IHC 1+ or greater in ≥50% tumor cells) relapsed or refractory sarcomas.
次要结局
- DCR(Up to 52 weeks)
- PK(Up to 52 weeks)
- Biomarker(Up to 52 weeks)
- PFS(Up to 52 weeks)
- ORR(Up to 52 weeks)
- DOR(Up to 52 weeks)
- TEAE(Up to 52 weeks)
研究者
研究点 (1)
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