A Clinical Research Evaluating the Safety and Efficacy of CD70-targeted CAR-NKT Cells (CGC738) Therapy in Subjects With Advanced Clear Cell Renal Cell Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 28
- 主要终点
- Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)
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 CGC738 in the treatment of advanced clear cell renal cell carcinoma (ccRCC).
详细描述
This is a single-arm, open-label study. This study will include two parts, dose escalation phase (3+3 design) followed by a dose expansion phase. All eligible participants will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by CAR-T cell injection.
Additional patients will be enrolled in the dose expansion phase to further characterize the safety profile and evaluate the efficacy of anti-CD70 CAR-T cell injection.
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.
- •2.ECOG 0-1 points.
- •The expected survival time is more than 3 months.
- •Patients with advanced ccRCC confirmed by histology or cytology to be recurrent or metastatic after at least first-line treatment.
- •IHC: CD70 positive.
- •At least one measurable lesion at baseline per RECIST version 1.
- •The functions of important organs are basically normal:
- •Pregnancy tests for women of childbearing age shall be negative, both men and women agreed to use effective contraception.
排除标准
- •Use of cell therapy within the previous one month.
- •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.
- •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.
- •Uncontrollable or significant heart disease.
- •Unstable respiratory diseases, including interstitial pneumonia.
- •Uncontrolled ascites and pleural effusion.
- •10.Known to have active or uncontrolled autoimmune diseases, such as Crohns disease, rheumatoid arthritis, systemic lupus erythematosus, etc.
- •11.Subjects who are using systemic steroids or steroid inhalers for treatment.
- •12.Pregnant or lactating female subjects.
- •13.Other investigators deem it unsuitable to participate in the study
研究组 & 干预措施
CAR-NKT Cells Lymphodepleting regimen
CAR-NKT Cells treatment
干预措施: CGC738 (Drug)
结局指标
主要结局
Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)
时间窗: Day 28 after CGC738 infusion
Dose limiting toxicity (DLT) is an AE that meets the following criteria and occurs within 28 days of CGC738 infusion.AE is graded according to CTCAE version 5.0.
次要结局
- ORR(Day 1 through week 56)
- DCR(Day 1 through week 56)
- AEs(Day 1 through week 56)