NL-OMON54482招募中2 期
A Phase 1, Open-Label, Multicenter, Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Allogeneic CRISPR-Cas9-Engineered T Cells (CTX130) in Adult Subjects with Advanced, Relapsed or Refractory Renal Cell Carcinoma (RCC) with Clear Cell Differentiation - CRSP-ONC-003 (3930/0017)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. >=18 years of age and body weight >=42 kg.
- •2. Able to understand and comply with protocol-required study procedures and
- •voluntarily sign a written informed consent document.
- •3. Diagnosed with unresectable or metastatic RCC with clear cell
- •differentiation:
- •Have previous exposure to both a CPI and a VEGF inhibitor and documented
- •progression after adequate exposure for favorable risk by International
- •Metastatic RCC Database Consortium criteria or a lack of response and/or
- •progression after adequate exposure for intermediate and poor risk
- •characteristics.
- •Have a previously pathologically confirmed diagnosis of RCC with clear cell
- •differentiation.
- •Availability of tumor tissues.
- •Have measurable disease as assessed by the investigator/site radiologist per
- •RECIST v1.1. Target lesions situated in a previously irradiated area are
- •considered measurable if progression has been demonstrated in such lesions.
- •Have at least 1 nontarget lesion that is suitable for biopsies.
- •4. Karnofsky performance status >=80% as assessed during the screening period.
- •5. Meets protocol-specified criteria to undergo daratumumab administration
- •(Parts A3 and A4 only), LD chemotherapy and CAR T cell infusion.
- •6. Adequate organ function:
- •Renal: Creatinine clearance >=50 mL/min.
- •* Aspartate aminotransferase and alanine aminotransferase < 3 x upper limit of
- •normal (ULN)
- •* Total bilirubin <2 x ULN (for Gilbert*s syndrome: total bilirubin < 3 mg/dL
- •and normal conjugated bilirubin)
- •* Albumin >90% of lower limit of normal.
- •Cardiac: Hemodynamically stable and left ventricular ejection fraction >=45%
- •by echocardiogram.
- •Pulmonary: Oxygen saturation level on room air >92% per pulse oximetry.
- •Hematologic: Platelet count >100,000/mm^3, absolute neutrophil count
- •>1500/mm^3, and hemoglobin >9 g/dL without prior blood cell transfusion before
- •Coagulation: Activated partial thromboplastin time or partial thromboplastin
- •time <=1.5 x ULN.
- •7. Female subjects of childbearing potential (postmenarcheal, has an intact
- •uterus and at least 1 ovary, and is less than 1 year postmenopausal) must agree
- •to use a highly effective method of contraception (as specified in the
- •protocol) from enrollment through at least 12 months after last CTX130
- •8. Male subjects must agree to use acceptable effective method of contraception
- •(as specified in the protocol) from enrollment through at least 12 months after
- •last CTX130 infusion.
排除标准
- •1. Prior treatment with any anti-CD70 targeting agents.
- •2. Prior treatment with any CAR T cells or any other modified T or natural
- •killer cells.
- •3. Known contraindications to daratumumab (Parts A3 and A4 only) any LD
- •chemotherapy agent(s) or any of the excipients of CTX130 product.
- •4. Subjects with central nervous system (CNS) manifestation of their malignancy
- •as evidenced by positive screening MRI or past history.
- •5. History or presence of clinically relevant CNS pathology such as seizure,
- •stroke, severe brain injury, cerebellar disease, history of posterior
- •reversible encephalopathy syndrome with prior therapy, or another condition
- •that in opinion of the investigator may increase CAR T cell-related toxicities.
- •6. Ongoing, clinically significant pleural effusion, or ascites or any
- •pericardial effusion, or a history of
- •pleural effusion or ascites in the last 2 months.
- •7. Unstable angina, clinically significant arrhythmia per investigator*s
- •judgement, or myocardial infarction within 6 months prior to screening.
- •8. Diabetes mellitus with a current hemoglobin A1c level of >7.0%.
- •9. Ongoing bacterial, viral, or fungal infection, requiring systemic
- •anti-infectives.
- •10. Positive for presence of human immunodeficiency virus type 1 or 2, or
- •active hepatitis B virus or hepatitis C virus infection. Subjects with prior
- •history of hepatitis B or C infection who have documented undetectable viral
- •load (by quantitative polymerase chain reaction or nucleic acid testing) are
- •11. Previous or concurrent malignancy, except those treated with curative
- •approach not requiring systemic therapy and have been in remission for >12
- •months, or any other localized malignancy that has a low risk of developing
- •into metastatic disease, per investigator*s judgement.
- •12. Primary immunodeficiency disorder or active autoimmune disease requiring
- •steroids and/or any other immunosuppressive therapy.
- •13. Prior solid organ transplantation or bone marrow transplant.
- •14. Use of systemic antitumor therapy or investigational agent, including
- •radiotherapy, within 14 days prior to enrollment. Use of physiological doses of
- •steroids (e.g. <=10mg/day prednisone or equivalent) will be permitted for
- •subjects previously on steroids if clinically indicated.
- •15. Received live vaccines or herbal medicines as part of traditional Chinese
- •medicine or non-over-the-counter herbal remedies within 28 days prior to
- •enrollment.
- •16. Diagnosis of significant psychiatric disorder that could seriously impede
- •the subject*s ability to participate in the study.
- •17. Pregnant or breastfeeding females.
研究者
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