NCT05757700进行中（未招募）1 期
A Phase I Study of T-cell Receptor Alpha Constant (TRAC) Locus Integrated CD19-Targeted 19(T2)28z1xx Chimeric Antigen Receptor (CAR) Modified T Cells in Adult Patients With CD19+ Relapsed or Refractory Large B-Cell Lymphoma
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
- 30
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
The purpose of this research is to evaluate if study therapy, 19(T2)28z1xx TRAC-chimeric antigen receptor (CAR) T cells, may be an effective treatment for people with relapsed/refractory B-cell lymphoma. Researchers will also evaluate if this study therapy is safe, and to look for the highest dose that causes few or mild side effects in participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Age ≥ 18 years of age
- •Creatinine ≤1.5 mg/100 ml or creatinine clearance ≥ 45ml/min/m2 , direct bilirubin ≤2.0 mg/100 ml, AST and ALT ≤3.0x upper limit of normal (ULN)
- •Adequate pulmonary function as assessed by ≥92% oxygen saturation on room air by pulse oximetry.
- •Histologically confirmed DLBCL and large B cell lymphoma, including
- •DLBCL, not otherwise specified (NOS), or
- •Transformed DLBCL from follicular lymphoma, or
- •High-grade B cell lymphoma (excluding Burkitt's lymphoma), or
- •Primary mediastinal large B cell lymphoma
- •Chemotherapy refractory disease, defined as a failure to achieve at least a partial response or disease progression within 12 months to the last therapy, OR
- •Disease progression or recurrence in ≤12 months of prior autologous stem cell transplant (ASCT), OR
- •Relapsed disease after 2 or more prior chemoimmunotherapies with at least one containing an anthracycline and CD20 directed therapy
- •Patients need to have radiographically documented disease
排除标准
- •ECOG performance status ≥
- •Pregnant or lactating women. Women and men of childbearing age should use effective contraception while on this study and continue for 1 year after all treatment is finished.
- •Active CNS disease
- •Impaired cardiac function (LVEF <40%) as assessed by ECHO or MUGA scan.
- •Patients with the following cardiac conditions will be excluded:
- •New York Heart Association (NYHA) stage III or IV congestive heart failure
- •Myocardial infarction ≤6 months prior to enrollment
- •History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration ≤6 months prior to enrollment
- •Patients with HIV or active hepatitis B or hepatitis C infection are ineligible.
- •Patients with prior allogeneic hematopoietic stem cell transplant are eligible, if more than 3 months from transplant and if patients have no active graft versus host disease (GvHD) and not on systemic immunosuppressive therapy.
- •Prior CD19-directed therapy including commercially approved or investigational CD19 CAR T cells or BiTEs is allowed, as long as expression of CD19 is confirmed by flow cytometry or immunohistochemistry.
- •Patients with uncontrolled systemic fungal, bacterial, viral or other infection are ineligible.
- •Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation or hormonal therapy, with the exception of squamous and basal cell carcinoma of the skin.
- •Patients with presence of clinically significant neurological disorders such as epilepsy, generalized seizure disorder, severe brain injuries are ineligible.
- •Any other issue which, in the opinion of the treating physician, would make the patient ineligible for the study.
研究组 & 干预措施
Participants with Diffuse Large B-Cell Lymphoma (DLBCL) and large B cell lymphoma
Experimental
Participants have histologically confirmed DLBCL and large B cell lymphoma. Participants will be treated with escalating doses of modified T cells.
干预措施: 19(T2)28z1xx TRAC T cell (Biological)
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: up to 1 year
The target toxicity rate for the MTD is
次要结局
未报告次要终点
研究者
研究点 (2)
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