A Phase 1/2 Trial of ADI-270 (Engineered γδ Chimeric Receptor [CAR] Vδ1 T Cells Targeting CD70) in Adults With Relapsed or Refractory (R/R) Clear Cell Renal Cell Carcinoma (ccRCC)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The Incidence of Subjects with Dose Limiting Toxicities within each dose level cohort
研究概览
简要总结
This is a Phase 1/2 multicenter, open-label, dose escalation, and dose expansion study of ADI-270 - an Engineered gamma-delta Chimeric Receptor [CAR] Vδ1 T Cell product Targeting CD70 - in patients with R/R ccRCC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed clear cell RCC
- •Documented evidence of advanced or metastatic diseases.
- •Patients must have been treated with an immune checkpoint inhibitor and a VEGF inhibitor (the VEGF inhibitor must have been administered in the advanced and/or metastatic setting).
- •At least one measurable target lesion according to RECIST 1.1
- •At least three weeks, or 5 half-lives, whichever is shorter, from the last dose of the prior line of systemic therapy
排除标准
- •Subjects with CNS metastases or spinal cord compression are not eligible, unless they have completed therapy and have discontinued the use of corticosteroids for at least 8 weeks and remained stable prior to enrollment.
- •Clinically significant CNS dysfunction of any etiology in the opinion of the Investigator.
- •Prior radiation therapy within 21 days prior to start of study treatment with the exception of palliative radiotherapy to bone lesions (palliative radiotherapy to bone lesions must be completed at least 2 weeks prior to the first dose of LD).
- •Active malignancy (except for RCC, definitively treated basal or squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix or bladder) within the past 24 months
- •Treatment with gene therapy, genetically modified cell therapy, or adoptive T cell therapy within 6 weeks before initiating LD in this study.
- •Receipt of CD70 targeted therapies for any indication
- •Require corticosteroid therapy > 5 mg per day of prednisone or equivalent.
- •History of any form of primary immunodeficiency such as severe combined immunodeficiency disease.
- •Presence of active autoimmune disease requiring ongoing systemic immunosuppressive therapy.
研究组 & 干预措施
Dose Escalation
ADI-270 is administered at ascending dose levels as a single dose to determine the maximum tolerated dose (MTD) or maximum assessed dose (MAD) of ADI-270
干预措施: Fludarabine (Drug)
Dose Expansion
Dose Expansion with ADI-270 at the MTD/MAD to confirm recommended phase 2 dose (Part 2).
干预措施: Fludarabine (Drug)
Dose Escalation
ADI-270 is administered at ascending dose levels as a single dose to determine the maximum tolerated dose (MTD) or maximum assessed dose (MAD) of ADI-270
干预措施: ADI-270 (Drug)
Dose Expansion
Dose Expansion with ADI-270 at the MTD/MAD to confirm recommended phase 2 dose (Part 2).
干预措施: ADI-270 (Drug)
Dose Escalation
ADI-270 is administered at ascending dose levels as a single dose to determine the maximum tolerated dose (MTD) or maximum assessed dose (MAD) of ADI-270
干预措施: Cyclophosphamide (Drug)
Dose Expansion
Dose Expansion with ADI-270 at the MTD/MAD to confirm recommended phase 2 dose (Part 2).
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
The Incidence of Subjects with Dose Limiting Toxicities within each dose level cohort
时间窗: Day 28
This primary endpoint will be used to determine the Maximum Tolerated Dose (MTD) or Maximum Assessed dose (MAD)
Proportion of treatment emergent and treatment related adverse events
时间窗: 2 years
This primary endpoint will be used to determine the MTD/MAD of ADI-270
次要结局
未报告次要终点