NCT06394622招募中1 期
A Clinical Research About CD70-targeted CAR-NKT Cells Therapy Advanced Malignant Solid Tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- ORR of CD70 CAR-NKT cell dynamics
研究概览
简要总结
This is a phase I, open-label, single-arm study conducted to evaluate the efficacy, safety and PK of CGC729 in the treatment of advanced malignant solid tumors.
Condition or disease:advanced malignant solid tumors. Intervention/treatment:Biological: CD70 CAR-NKT cells. Phase:I
详细描述
This was a dose-expansion study, we plan to enroll 6 to 12 patients with CD70-positive advanced malignant solid tumors to CGC729 treatment. The intended enrollment for the evaluation of treatment efficacy and safety was planned to be 3 to 6 patients per tumor type.
We used leukapheresis for cell collection. The lymphodepletion procedure was conducted using a combination of fludarabine and cyclophosphamide.
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
- •Age 18 to 75 years.
- •ECOG 0-1 points.
- •The expected survival time is more than 3 months.
- •Patients with advanced advanced malignant solid tumor confirmed by histology or cytology to be recurrent or metastatic after at least second-line treatment.
- •IHC: CD70 positive.
- •At least one measurable lesion at baseline per RECIST version 1.
- •The functions of important organs are basically normal:Hematopoietic function:
- •neutrophils 1.5×109/L, platelets 75×109/L, hemoglobin 80g/L;Renal function: creatinine clearance of ≥60 mL/min.;Liver function: ALT and AST ≤2.5×ULN (≤5 × ULN for patients with liver metastases);Total bilirubin ≤1.5×ULN.Prothrombin time (PT) : INR < 1.
- •Pregnancy tests for women of childbearing age shall be negative, Both men and women agreed to use effective contraception.
- •Subjects or their guardians agree to participate in this clinical trial and sign the ICF, indicating that they understand the purpose and procedures of this clinical trial and are willing to participate in the research.
排除标准
- •Use of cell therapy within the previous one month.
- •Risk of severe bleeding in esophageal cancer
- •Subjects with other malignant tumors within the past 2 years, except basal or squamous skin cancer, superficial bladder cancer, and breast cancer in situ, have been completely cured and do not need follow-up treatment.
- •Patients with leptomeningeal metastasis or central nervous system metastasis, and definite central nervous system underlying diseases with significant symptoms in the past 6 months.
- •Immunotherapy, targeted drug therapy or chemotherapy within 5 drug half-lives within 2 weeks before cell infusion.
- •Active hepatitis B, HIV positive and HCV positive
- •Active infection or uncontrollable infection.
- •Subjects with NYHA heart failure class ≥2 or hypertension uncontrolled by standard therapy requiring special treatment, previous history of myocarditis, or myocardial infarction within 6 months.
- •Unstable respiratory diseases, including interstitial pneumonia.
- •Uncontrolled ascites and pleural effusion
- •Known to have active or uncontrolled autoimmune diseases, such as Crohns disease, rheumatoid arthritis, systemic lupus erythematosus, etc. .
- •Subjects who are using systemic steroids or steroid inhalers for treatment.
- •Pregnant or lactating female subjects.
- •Other investigators deem it unsuitable to participate in the study.
结局指标
主要结局
ORR of CD70 CAR-NKT cell dynamics
时间窗: Day 1 through week 56
Assess Objective response rate
次要结局
- DCR of CD70 CAR-NKT cell dynamics(Day 1 through week 56)
- PFS of CD70 CAR-NKT cell dynamics(Day 1 through week 56)
- DOR of CD70 CAR-NKT cell dynamics(Day 1 through week 56)
- OS of CD70 CAR-NKT cell dynamics(Day 1 through week 56)
研究者
Jian Zhang,MD
Head of Phase I Clinical Trial Center
Fudan University
研究点 (1)
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