A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of LUCAR-20S in Patients With Relapsed/Refractory Diffuse Large B-Cell, Follicular, Mantle Cell or Small Lymphocytic Lymphoma
概览
- 阶段
- 1 期
- 干预措施
- LUCAR-20S CAR-T cells
- 疾病 / 适应症
- Diffuse Large B Cell Lymphoma
- 发起方
- The First Affiliated Hospital with Nanjing Medical University
- 入组人数
- 7
- 试验地点
- 3
- 主要终点
- Dose limiting toxicity (DLT)
- 状态
- 终止
- 最后更新
- 4年前
概览
简要总结
An open label, single arm Phase I study to evaluate the safety, tolerability, and pharmacokinetics of LUCAR-20S CAR-T cells in relapsed or refractory CD20+ diffuse large B-cell, follicular, mantle cell and small lymphocytic lymphoma.
详细描述
This study is an open, dose escalation/dose regimen finding study to assess the safety and pharmacokinetics of donor-derived CD20-directed CAR-T cells administered with lymphodepletion, and to obtain the preliminary efficacy results in subjects who have been diagnosed with relapsed or refractory CD20 positive diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma or small lymphocytic lymphoma. The allo-CAR-T cells will be infused in single-dose.
研究者
WEI XU
Chief Physician of hematology department
The First Affiliated Hospital with Nanjing Medical University
入排标准
入选标准
- •Signed informed consent form (ICF)
- •Age 18 Years to 75 Years
- •Pathological diagnosis of refractory/relapsed CD20+ non-Hodgkin's lymphoma (one of the following):
- •Diffuse large B-cell lymphoma (DLBCL)
- •Follicular lymphoma (FL)
- •Mantle cell lymphoma (MCL)
- •Small lymphocytic lymphoma (SLL)
- •Measurable disease as defined by 2014 Lugano criteria at Screening
- •Refractory/relapsed disease after standard-of- care treatment as following (Undergone at least 2 complete cycle of therapy for each line, unless PD been documented as the best response to the regimen) and not eligible or appropriate for HSCT (Auto/allo). Subject must have documented evidence of progressive disease on or within 12 months of their last regimen.
- •DLBCL: Refractory/relapsed after at least 1 prior line of therapy, must have been treated with anti-CD20 monoclonal antibody
排除标准
- •Any malignancy besides the NHL categories under study, exceptions include
- •Any other malignancy curatively treated and disease-free for at least 2 years prior to enrollment
- •History of non-melanoma skin cancer with sufficient treatment and currently no evidence of recurrence
- •Prior treatment with an allogeneic stem cell transplant
- •Prior treatment with genetic therapy
- •Prior treatment with chimeric antigen receptor T (cells) CAR-T therapy directed at CD20 target
- •Those who are positive for any index of hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), and human immunodeficiency virus antibody (HIV-Ab)
- •Prior antitumor therapy with insufficient washout period
- •Targeted therapy, epigenetic therapy, experimental drug therapy or experimental invasive treatment with medical apparatus and instruments 14 days or five half-lives, whichever is shorter before lymphodepletion
- •Use of monoclonal antibodies 21 days prior to lymphodepletion
研究组 & 干预措施
Anti-CD20 Allogeneic CAR-T Cell Therapy
An open label, single arm Phase I study to evaluate the safety, tolerability, and pharmacokinetics of LUCAR-20S CAR-T cells in relapsed or refractory CD20+ diffuse large B-cell, follicular, mantle cell and small lymphocytic lymphoma.
干预措施: LUCAR-20S CAR-T cells
结局指标
主要结局
Dose limiting toxicity (DLT)
时间窗: 30 days post infusion
DLT assessed by NCI-CTCAE 5.0
Concentration of Pharmacokinetics in blood
时间窗: through study completion, 2 years after infusion of the last subject
PK CAR positive T cells in peripheral blood, PK CAR transgene levels in peripheral blood
Adverse events
时间窗: 90 days post infusion
Incidence and severity of adverse events as assessed by NCI-CTCAE 5.0
Concentration of Pharmacokinetics in bone marrow
时间窗: through study completion, 2 years after infusion of the last subject
PK CAR positive T cells in bone marrow, PK CAR transgene levels in bone marrow
次要结局
- Overall response rate (ORR) after administration(3 months post infusion)
- Recommended Phase II dose (RP2D)(30 days post infusion)
- Time to Response (TTR) after administration(3 months post infusion)
- Duration of remission (DOR) after administration(through study completion, 2 years after infusion of the last subject)
- Progress Free Survival (PFS) after administration(through study completion, 2 years after infusion of the last subject)
- Overall Survival (OS) after administration(through study completion, 2 years after infusion of the last subject)