NCT06420089招募中1 期
CD5-deleted Chimeric Antigen Receptor Cells (Senza5 CART5) to Enhance Immunotherapy Against T Cell Non-Hodgkin Lymphoma (NHL): a First-in-human Phase I Clinical Trial
Vittoria Biotherapeutics2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年10月4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
- 30
- 试验地点
- 2
- 主要终点
- Determine the recommended phase 2 dose (RP2D) of Senza5 CART5 cells
研究概览
简要总结
This is an open-label phase I study to determine the safety and recommended phase 2 dose (RP2D) of Senza5 CART5 cells in patients with relapsed or refractory CD5 positive nodal T cell NHL. RP2D will be based on the safety, tolerability, pharmacokinetics, and preliminary efficacy of Senza5 CART5 cells. This trial will evaluate up to 5 dose levels using the Bayesian Optimal Interval (BOIN) design enrolling 3 patients in each cohort to assess safety and achieve therapeutic levels so that the RP2D of Senza5 CART5 cells given as a single IV infusion can be determined.
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 relapsed or refractory (r/r) CD5-positive nodal peripheral T-cell lymphoma (such as peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), nodal T-cell lymphomas with T-follicular helper (TFH) phenotype, including follicular T cell lymphoma, angioimmunoblastic lymphoma, or anaplastic large cell lymphoma) or other non-leukemic CD5+ aggressive mature T cell lymphomas (such as enteropathy-associated T cell lymphoma, monomorphic epitheliotropic intestinal T cell lymphoma, transformed mycosis fungoides, primary cutaneous aggressive epidermotropic CD8+ cytotoxic T-cell lymphoma, primary cutaneous insert gamma delta symbols lymphoma, or subcutaneous panniculitis like T cell lymphoma).
- •≥50% expression of CD5 on flow cytometry or IHC on malignant cells on the most recent biopsy
- •Must have received at least one line of prior systemic therapy for their lymphoma; participants with anaplastic large cell lymphoma (ALCL) must have received prior brentuximab unless there was a contraindication to brentuximab.
- •Evaluable disease defined by at least one lesion that can be measured in least 1 dimension and measures at least 1.5 cm in its longest dimension by CT or PET scan, or bone/bone marrow involvement, or skin involvement.
- •No circulating CD5+ malignant cells identified by peripheral blood flow cytometry must be present.
排除标准
- •Pregnant or lactating (nursing) women.
- •HIV infection.
- •Concurrent use of systemic steroids or immunosuppressant medications.
- •Any uncontrolled active medical disorder that would preclude participation as outlined.
- •History of immunodeficiency.
- •History of prior chimeric antigen receptor therapy (CAR T), autologous or syngeneic HCT <100 days from transplant at the time of cell infusion or previous allo-HCT.
- •Active and/or systemic inflammatory or autoimmune diseases.
- •Signs or symptoms indicative of active CNS involvement.
- •Known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system, and unrelated to lymphoma or previous lymphoma treatment.
- •Clinically apparent arrhythmia, or arrhythmias that are not stable on medical management
- •Current participation in or prior participation in a study of an investigational agent or using an investigational device within 2 weeks of the first dose of treatment.
- •Prior monoclonal antibody therapy within 4 weeks prior to study Day 1
- •Prior use of alemtuzumab
- •Prior chemotherapy targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1
- •Uncontrolled active infection requiring systemic therapy.
- •Circulating CD5+ malignant cells identified by peripheral blood flow cytometry present.
- •Active and/or systemic inflammatory or autoimmune diseases.
研究组 & 干预措施
Senza5 CART5 with standard of care lymphodepletion
Experimental
Four treatment arms with Standard of Care Lymphodepletion:
Fludarabine 25mg/m2 IV for 3 days Cyclophosphamide 250mg/m2 IV for 3 days
干预措施: Senza5 CART5 (Drug)
Senza5 CART5 without standard of care lymphodepletion
Experimental
Four treatment arms in patients are lymphopenic into the corresponding dose level.
干预措施: Senza5 CART5 (Drug)
结局指标
主要结局
Determine the recommended phase 2 dose (RP2D) of Senza5 CART5 cells
时间窗: 12 months
Measure the occurrence of Dose Limiting Toxicity events of each dose level per arm
次要结局
- Determine the maximum tolerated dose (MTD)(12 months)
- Determine efficacy of Senza5 CART5(12 months)
- Determine the safety of Senza5 CART5 cells(12 months)
- Determine the manufacturing feasibility of Senza5 CART5(12 months)
研究者
研究点 (2)
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