NCT05122221招募中1 期
A Phase I Study to Evaluate the Safety, Tolerance and Efficacy of CRTE7A2-01 TCR-T Cell for HPV16 Positive Advanced Cervical, Anal, or Head and Neck Cancers
Corregene Biotechnology Co., Ltd1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2022年7月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- DLT
研究概览
简要总结
A single center, open, single arm dose escalation phase I study to evaluate the safety, tolerability, and efficacy of CRTE7A2-01 TCR-T cell for HPV16 positive advanced cervical, anal, or head and neck cancers. The study will determine MTD of CRTE7A2-01 TCR-T cell injection, as well as investigate RP2D.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years and ≤65 years.
- •Histologically-confirmed cervical cancer, anal cancer, head and neck cancers with confirmed HPV16 infection and HLA-A*02:01 allele
- •Failure on or intolerance to systemic therapy for unresectable advanced cancer.
- •ECOG performance status of 0-
- •Estimated life expectancy ≥ 3 months.
- •Patients must have at least one measurable lesion defined by RECIST 1.
- •Female patients of childbearing age must undergo a serum pregnancy test within 7 days prior to study treatment and the results must be negative, and are willing to use a very effective and reliable method of contraception from screening through 6 months after the last dose of study treatment.
- •The patient must be willing to sign the informed consent form and have a good anticipation of compliance with study procedure.
- •Exclusion Criteria：
- •The proportion of T cell immune-related gene deletion mutations>5%.
- •Patient received any genetically modified T cell therapy.
- •Patient who is being treated with T cell immunosuppressive agent （such as cyclophosphamide, FK506,tripterygium glycosides） or T cell immunoagonist.
- •Patients received chemotherapy, targeted therapy, immunotherapy, or other investigational agents within 2 weeks and received radiotherapy within 4 weeks before apheresis.
- •Patients with any organ dysfuntion as defined below:
- •leukocytes<3.0 x 109/L
- •absolute neutrophil count >1.5 x 109/L
- •hemoglobin<90g/L
- •platelets <100 x 1010/L
- •lymphocytes<0.8 x 109/L
- •percentage of lymphocytes<15%
- •creatinine>1.5×ULN or creatinine clearance <50mL/min
- •total bilirubin>3×ULN; ALT/AST>3×ULN (patients with liver metastasis,>5×ULN)
- •INR>1.5×ULN; APTT>1.5×ULN
- •Patients with serious medical conditions, disorders, and / or comorbidities, including, but are not limited to: severe heart disease, cerebrovascular disease, epileptic seizures, uncontrolled diabetes (CTCAE 5.0: FBG ≥ 2 grade), active infection, active digestive tract Ulcer, gastrointestinal bleeding, intestinal obstruction, pulmonary fibrosis, renal failure, respiratory failure.
- •Patient with a severe cardiovascular disease with 6 months before screening, including, but are not limited to, myocardial infarction, severe or unstable angina, coronary or peripheral artery bypass grafting, Heart failure NYHA grade Ⅲ or Ⅳ.
- •Left Ventricular Ejection Fractions (LVEF) <50%.
- •Patient with a known active brain metastases.
- •Patient with a known myelodysplastic syndrome (MDS) or lymphoma.
- •Patient with a known active autoimmune disease, including , but are not limited to, acquired or congenital immunodeficiency disease, allogeneic organ transplantation, autoimmune hepatitis, systemic lupus erythematosus, inflammatory bowel disease.
- •Patient with a known active Hepatitis B or Hepatitis C.
- •Patient with a history of Human Immunodeficiency Virus (HIV) .
- •Patient with a history of syphilis.
- •Pregnant or lactating women.
- •Patient with a known active mental and neurological diseases.
- •The principal investigator judged that it is not suitable to participate in this clinical study.
排除标准
- 未提供
研究组 & 干预措施
CRTE7A2-01 TCR-T cell therapy
Experimental
Patients will undergo lymphocytapheresis, then treatment with TCR-T cell (at escalating doses) + IL-2
干预措施: Fludarabine + Cyclophosphamide (Drug)
CRTE7A2-01 TCR-T cell therapy
Experimental
Patients will undergo lymphocytapheresis, then treatment with TCR-T cell (at escalating doses) + IL-2
干预措施: Interleukin-2 (Drug)
CRTE7A2-01 TCR-T cell therapy
Experimental
Patients will undergo lymphocytapheresis, then treatment with TCR-T cell (at escalating doses) + IL-2
干预措施: CRTE7A2-01 TCR-T Cell (Biological)
结局指标
主要结局
DLT
时间窗: 28 days
Dose-limiting toxicity
RP2D
时间窗: 28 days
Recommended Phase II Dose
Incidence of treatment related AEs, AEs of special interest and serious adverse events (SAEs).
时间窗: 2 years
grade 1-5 (CTCAE)
MTD
时间窗: 28 days
Maximum Tolerated Dose
次要结局
- Objective Response Rate（ORR）(2 years)
- Duration of Response（DOR）(2 years)
- Disease Control Rate（DCR）(2 years)
- Progression-Free Survival（PFS）(2 years)
研究者
研究点 (1)
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