NCT04696731进行中（未招募）1 期
A Phase 1A/1B Multicenter Study Evaluating the Safety and Efficacy of ALLO-316 With Cyclophosphamide/Fludarabine Lymphodepletion Alone or Including ALLO-647 in Subjects With Advanced or Metastatic Clear Cell Renal Cell Carcinoma (ccRCC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 12
- 主要终点
- Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-316
研究概览
简要总结
This is a Phase 1 dose escalation study using a 3+3 study design, followed by a phase 1b expansion study. The purpose of the TRAVERSE study is to assess the safety, efficacy, and cell kinetics of ALLO-316 in adults with advanced or metastatic clear cell renal cell carcinoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, with or without ALLO-647 to define a Phase 2 dose.
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed renal cell carcinoma with a predominant clear cell component.
- •Must have received a checkpoint inhibitor and a VEGF inhibitor in the advanced and/or metastatic setting.
- •At least one measurable lesion as defined by RECIST version 1.1
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or
- •Absence of donor (product)-specific anti-HLA antibodies (DSA).
- •Adequate hematological, renal, liver, pulmonary, and cardiac functions.
排除标准
- •Central nervous system (CNS) metastatic disease (unless controlled and stable for at least 4 weeks), leptomeningeal disease, or cord compression.
- •Clinically significant CNS dysfunction.
- •Any other active malignancy within 3 years prior to enrollment.
- •Prior treatment with anti-CD70 therapies.
- •Current thyroid disorder (including hyperthyroidism) with the exception of hypothyroidism controlled on stable dose of hormone replacement therapy.
- •Prior treatment with anti-CD52 monoclonal antibody in the past 12 months.
- •Participants unwilling to participate in the extended safety monitoring period.
研究组 & 干预措施
ALLO-647, ALLO-316
Experimental
干预措施: Fludarabine (Drug)
ALLO-647, ALLO-316
Experimental
干预措施: ALLO-316 (Genetic)
ALLO-647, ALLO-316
Experimental
干预措施: ALLO-647 (Biological)
ALLO-647, ALLO-316
Experimental
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-316
时间窗: 33 days
Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-316
时间窗: 28 days
次要结局
未报告次要终点
研究者
研究点 (12)
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相关资讯
Global CD70-Targeting Therapies Market Report 2026 Highlights Expanding Pipeline and Combination Strategies- A new market report forecasts continued expansion of the global CD70-targeting therapies pipeline across the United States, China, and Europe as candidates advance through clinical trials and regulatory review.
- Clinical development increasingly incorporates combination regimens pairing CD70 therapies with immunotherapies, epigenetic inhibitors, chemotherapy, and targeted agents to strengthen responses and address resistance.
- Leading companies including Allogene Therapeutics, Ambrx (Johnson & Johnson), Molecular Partners, and CRISPR Therapeutics are advancing differentiated programs through proprietary platforms such as allogeneic cell therapy and DARPin engineering.
- The report highlights biomarker-driven development and patient-selection strategies as key levers for more precise clinical positioning across leukemia, lymphoma, renal cell carcinoma, and autoimmune indications.22 days agoALLO-316 CAR-T Therapy Shows Promise in Renal Cell Carcinoma Trial, but Deaths Reported• Allogene's ALLO-316 demonstrated a 38% overall response rate in renal cell carcinoma patients at dose level 2 in the TRAVERSE phase 1 trial.
• In patients with high CD70 expression, ALLO-316 achieved a confirmed overall response rate of 33%, indicating potential for targeted therapy.
• The trial reported a manageable safety profile, with mostly low-grade cytokine release syndrome, but included three on-study patient deaths.
• ALLO-316, an off-the-shelf CAR-T therapy, shows potential as a novel treatment for metastatic RCC resistant to multiple therapeutic classes.last yearALLO-316 Demonstrates Promising Response in CD70-Positive Renal Cell Carcinoma• A phase 1 trial of ALLO-316 showed a 50% overall response rate in patients with CD70-positive renal cell carcinoma (RCC) with a tumor proportion score (TPS) of ≥50%.
• The study also reported a 33% confirmed response rate among patients with CD70-positive RCC, indicating potential efficacy in heavily pretreated patients.
• The most common adverse events were cytokine release syndrome, fatigue, and neutropenia, with a manageable safety profile observed in the trial.
• These findings suggest that ALLO-316, an off-the-shelf CAR T-cell therapy, could represent a significant advancement in treating advanced RCC.last yearALLO-316 Receives FDA RMAT Designation for CD70+ Advanced Renal Cell Carcinoma• The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-316 for CD70-positive advanced or metastatic renal cell carcinoma.
• The RMAT designation was supported by phase 1 TRAVERSE trial data, which showed promising overall response and disease control rates.
• In CD70-positive patients, ALLO-316 demonstrated a 30% overall response rate and a 100% disease control rate in the trial.
• ALLO-316's adverse effect profile was consistent with autologous CAR T-cell therapies, with manageable safety observed in the trial.last yearALLO-316 Granted RMAT Designation by FDA for Advanced Renal Cell Carcinoma- The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-316 for advanced or metastatic renal cell carcinoma.
- The RMAT designation aims to expedite the development and review of ALLO-316, an AlloCAR T therapy.
- Phase 1 TRAVERSE trial data supports the RMAT designation, showing promising disease control and response rates in CD70-expressing RCC patients.
- ALLO-316 demonstrated a manageable safety profile, consistent with other CAR T therapies, in heavily pretreated patients.last year