Immunotherapy With Autologous CAR30 T Cells for Patients With Classic Hodgkin Lymphoma and Non-Hodgkin T-cell Lymphoma With CD30 Expression.
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- To assess safety and toxicity of the administration of autologous anti-CD30 CAR T-cells
研究概览
简要总结
HSP-CAR30 is a cell suspension of genetically modified T-cells to express a second generation (4-1BBz) chimeric antigen receptor (CAR) directed against CD30.
This is a phase I/IIa, interventional, single arm, open label, treatment study to evaluate the safety, tolerability and efficacy of HSP-CAR30 in patients with relapsed/refractory Hodgkin lymphoma and relapsed/refractory T-cell lymphoma expressing CD30.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Classic Hodgkin lymphoma:
- •Relapsed patients after autologous hematopoietic stem cell transplantation who have already received Brentuximab-Vedotin and anti-PDL1 antibodies, OR
- •Primarily refractory patients who do not reach CR after rescue, including Brentuximab-Vedotin and anti-PDL1 antibodies.
- •Anaplastic large T-cell lymphoma (ALK+/ALK-) and peripheral T-cell lymphoma (NOS/Angioimmunoblastic):
- •>90% of tumor cells expressing CD30 determined by immunohistochemistry, AND
- •Relapsed patients after autologous hematopoietic stem cell transplantation, OR
- •Primarily refractory patients (after first line, including anthracycline) who do not achieve CR after rescue.
- •All patients must sign an informed consent before starting any procedure.
- •All patients must have measurable disease (detected by PET-CT) at the time of inclusion.
- •Performance status: ECOG 0-1
- •FEV1> 39%; DLCO and FVC> 39% of NV.
- •No significant ventricular dysfunction: EF >45%.
- •Total bilirubin and transaminases <3 times the maximum normal value, unless attributable to lymphoma.
- •Creatinine <2 times the normal maximum value and clearance> 40 mL/min.
排除标准
- •Performance status: ECOG 2-4
- •Prior allogeneic haematopoietic stem cell transplant.
- •Active hepatitis B, C or HIV infection
- •Active bacterial, fungal, or viral infection.
- •Evidence of CNS involvement by lymphoma.
结局指标
主要结局
To assess safety and toxicity of the administration of autologous anti-CD30 CAR T-cells
时间窗: 12 months
Number of patients with cytokine release syndrome and/or ICANs grade 1-4 according to ASBMT Consensus
To analyze the rate of complete responses at 3 months after the procedure
时间窗: 24 months
To establish the maximum tolerated dose (MTD; defined as the dose that induces maximum limiting toxicity) of autologous anti-CD30 CAR T-cells in patients with refractory or relapsed classic Hodgkin or CD30 + T NHL.
时间窗: 12 months
Number of patients receiving maximum dose (1 x 10e7/kg CART+ cells) without DLT
次要结局
未报告次要终点