NCT06514794招募中2 期
A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in Patients With Relapsed/Refractory Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-RRex)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 18
- 主要终点
- R/R Cohort - Composite Complete Response Rate
研究概览
简要总结
The T-RRex study evaluates the efficacy of WU-CART-007 for patients with Relapsed/Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL) and to WU-CART-007 as a therapy to induce complete Minimum Residual Disease (MRD) negative response
详细描述
This is a Phase 2, single-arm, multi-center, open label study in patients with R/R T-ALL/LBL and T-ALL/LBL in remission but remaining MRD positive.
研究设计
- 研究类型
- 干预性
- 分配方式
- 不适用
- 干预模型
- 单组
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Disease Criteria: Evidence of T-ALL or T-LBL, as defined by World Health Organization (WHO) classification, and either relapse/refractory or MRD positive
- Age: Lower age limit of ≥ 6 months; adequate organ function
- Eastern Cooperative Oncology Group (ECOG) 0 or 1/Karnofsky Performance Status 70 and above at Screening.
- Key
排除标准
- Prior treatment with any anti-CD7 therapy.
- Patients with decompensated hemolytic anemia.
- Presence of Grade 2 to 4 acute or extensive chronic GvHD requiring systemic immunosuppression. Grade 1 GvHD not requiring immunosuppression or Grade 2 skin GvHD if treated with topical therapy only are acceptable.
研究组 & 干预措施
WU-CART-007
Experimental
A CD7-directed chimeric antigen receptor (CAR) T-cell product.
Lymphodepletion
干预措施: WU-CART-007 (Biological)
结局指标
主要结局
R/R Cohort - Composite Complete Response Rate
时间窗: 24 months
CRc is defined as proportion of patients that achieve a complete remission (CR) + CR with incomplete hematologic recovery (CRi)
MRD Pos Cohort - Response Rate
时间窗: 24 months
Defined as the efficacy of WU-CART-007 to induce complete MRD negative response
次要结局
未报告次要终点
研究者
研究点 (18)
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标识符
- NCT 编号
- NCT06514794
- 其他研究编号
- WUC007-03
日期
- 首次提交
- (2年前)
- 首次发布
- (2年前)
- 主要完成日期
- (3个月后)
- 研究完成日期
- (2年后)
- 最近核实
- (2个月前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 是
- FDA 监管器械
- 否
- 是否有结果
- 否
相似试验
已完成
1 期
同适应症A Phase 1 Study of of Anti-CD7 Allogeneic CAR-T Cell Therapy (WU-CART-007) in Patients With Relapsed or Refractory T-ALL/LBLLymphoblastic LymphomaT-cell Acute Lymphoblastic LeukemiaNCT04984356Wugen, Inc.28
尚未招募
不适用
同适应症Autologous Versus Allogeneic Hematopoietic Stem Cell Transplantation for T-Lymphoblastic Leukemia/Lymphoma in First Complete RemissionT Cell Acute Lymphoblastic Leukemia/Lymphoblastic LymphomaNCT07577531Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine84
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同适应症CD7-CAR-T Cells in Pediatric Relapsed/Refractory CD7+ T-ALL/LLT-Cell Acute Lymphoblastic Leukemia/Lymphoblastic LymphomaNCT06064903Bambino Gesù Hospital and Research Institute26
已完成
1 期
同适应症Cell Therapy for CD7 Positive T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Using CD7-Specific CAR-T CellsT-cell Acute Lymphoblastic Leukemia/LymphomaNCT04572308Hebei Senlang Biotechnology Inc., Ltd.20
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1 期
同适应症Anti-CD7 CAR-T Cells in Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia or LymphomaT-Cell Acute Lymphoblastic Leukemia/LymphomaNCT06934382Stephan Grupp MD PhD33
相关资讯
Allotera Therapeutics Closes $35 Million Financing, Bringing Total to $150 Million for Pivotal-Stage Off-the-Shelf CAR-T Therapy in T-Cell Cancers- Allotera Therapeutics (formerly Wugen) closed a $35 million financing round including equity and venture debt, bringing total Series C capital raised to $150 million.
- Proceeds will support the global pivotal T-RRex trial of Soficabtagene Geleucel (Sofi-cel), an allogeneic CD7-targeted CAR-T therapy for relapsed/refractory T-ALL and T-LBL.
- Sofi-cel uses CRISPR/Cas9 gene editing to delete CD7 and TRAC genes, preventing CAR-T fratricide and reducing graft-versus-host disease risk.
- The therapy holds Breakthrough Therapy, RMAT, Fast Track, Orphan Drug, Rare Pediatric Disease, and PRIME designations from the FDA and EU regulators.2 months agoWugen's Allogeneic CAR-T Therapy Shows Promising Long-Term Survival Data in T-Cell Leukemia Patients- Wugen's investigational allogeneic CAR-T therapy Soficabtagene Geleucel demonstrated over one-hundred-fold expansion and persisted in circulation for up to three months in Phase 1/2 studies.
- Three patients who received successful allogeneic stem cell transplants remain alive approximately two years after Sofi-cel infusion, with no late adverse events of special interest reported.
- The therapy uses CRISPR/Cas9 gene editing to delete CD7 and TRAC genes, preventing CAR-T cell fratricide and reducing graft-versus-host disease risk.
- The pivotal Phase 2 T-RRex study is currently enrolling patients aged ≥1 year with relapsed or refractory T-ALL/LBL, representing a potential first-in-class treatment.9 months agoWugen Initiates Pivotal Trial of Novel Off-the-Shelf CAR-T Therapy for Rare Blood Cancers- Wugen has dosed the first patients in its pivotal Phase 2 T-RRex study of WU-CART-007, an allogeneic CD7-targeted CAR-T therapy for relapsed/refractory T-ALL/LBL.
- Previous Phase 1/2 data showed promising results with a 91% overall response rate and 73% complete remission rate in heavily pretreated patients, addressing a therapeutic area with no new approvals in 20 years.
- The investigational therapy has received multiple accelerated approval designations from the FDA and EU regulatory bodies, including RMAT, Fast Track, Orphan Drug, and PRIME designations.last yearWU-CART-007 Demonstrates High Response Rates in Relapsed/Refractory T-ALL/LBL- WU-CART-007, an allogeneic CD7-targeted CAR T-cell therapy, shows promising antileukemic activity in heavily pretreated R/R T-ALL/LBL patients.
- The Phase 2 trial data reveals a 91% overall response rate and a 73% composite complete remission rate among evaluable patients.
- Cytokine release syndrome was common but manageable, and neurotoxicity was infrequent, highlighting an acceptable safety profile.
- A pivotal Phase 2 trial is set to begin in late 2024, including pediatric patients, to further evaluate WU-CART-007 in R/R T-ALL/LBL.last year