NCT05349266Unknown1 期
Assessment of Safety and Efficacy of ThisCART19A in Adult Patients With B Cells Non-Hodgkin's Lymphoma(B-NHL) After Failure of Autologous CAR-T Therapy
Zhejiang University1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2022年3月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Dose limited toxicity(DLT) observation in patient with NHL during dose escalation stage
研究概览
简要总结
This is a phase I, single center study to assess the efficacy and safety of ThisCART19A in adult with Non-Hodgkins Lymphoma in China.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cellular or histopathological diagnosis of B-cell non-Hodgkin's lymphoma (B-NHL) includes: diffuse Large B-cell lymphoma (DLBCL), follicular lymphoma to DLBCL (tFL), follicular lymphatic (FL), Mantle cell lymphoma (MCL), primary Mediastinal Large B-cell lymphoma (PMBCL), etc.
- •Failing to autologous CAR-T therapy.
- •At least one available lesion to be assessed.
- •Good organ function during screening.
- •Should be confirmed Cluster of differentiation(CD)19 positive by biopsy for the patient who received target CD19 therapy before.
排除标准
- •Allergic to preconditioning measures.
- •Patients with other malignancies other than B-cell malignancies within 5 years prior to screening. Patients with cured skin squamous carcinoma, basal carcinoma, non-primary invasive bladder cancer, localized low-risk prostate cancer, in situ cervical/breast cancer can be recruited.
- •Uncontrollable bacterial, fungal and viral infection during screening.
- •Patients had pulmonary embolism within 3 months prior to enrollment.
- •Had intolerant severe cardiovascular and cerebrovascular diseases and hereditary diseases prior to enrollment.
- •Imaging confirmed the presence of central nervous system involvement (both primary and secondary) and obvious symptoms at the time of screening.
- •Active hepatitis B virus (HBV) or hepatitis C virus (HCV) or Human immunodeficiency virus (HIV) or Syphilis infection. HBV-DNA < 2000 IU/mL can be enrolled, but should admitted to use anti-virus drugs such as entecavir, tenofovir, etc, and supervisory the relative indication during the treatment.
- •Had big lesion(single lesion diameter ≥10 cm).
- •Bone marrow involvement≥5%.
- •Receive allogeneic hematopoietic stem cell transplantation less than 100 days.
- •Combined systemic steroid use (e.g., prednisone ≥20mg) within 3 days prior to screening. Or systemic diseases that require long-term use of immunization Inhibitor.
- •Vaccinated with influenza vaccine within 2 weeks prior to lymphodepleting chemotherapy (Severe Acute Respiratory Syndrome-Corona virus disease 19 can be included, inactivated, live/non-live adjuvant vaccinations allowed to be included) .
- •Patients who are receiving Graft versus host disease Hepatitis(GvHD) treatment; Patients without GvHD and who had stopped immunosuppressive drugs for at least 1 month were eligible for inclusion.
- •Women who are in pregnant or lactating, and female subjects or partners who plan to be pregnant within 1 year after cell infusion. Male subjects who plan pregnancy within 1 year after infusion.
结局指标
主要结局
Dose limited toxicity(DLT) observation in patient with NHL during dose escalation stage
时间窗: 28 days
DLT is defined as the incidence of severe adverse events related to ThisCART19A more than 33% in each dose level.
Objective Response Rate in patient with NHL during dose expansion stage
时间窗: 12 months
the incidence of complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or unevaluable (UE) as best response to treatment
次要结局
- Duration of response(DOR) during dose escalation stage and expansion stage(12 months)
- Objective Response Rate during dose escalation stage and expansion stage(12 months)
- OS(overall survival) during dose escalation stage and expansion stage(12 months)
- Time to remission(TTR) during dose escalation stage and expansion stage(12 months)
- Analysis the change characteristics of CART cell number and copy number during dose escalation and expansion stages(6 months)
- Analysis the change characteristics of cytokines and immune effect cells number during dose escalation and expansion stages(3 months)
- Analysis the immunogenicity(anti-therapeutic antibody and neutralizing antibody) of CAR-T cells after infusion(12 months)
- Analysis the severity and Incidence of Adverse Events in each dose level during dose expansion stage(3 months)
研究者
He Huang
President/Proffessor
First Affiliated Hospital of Zhejiang University
研究点 (1)
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