NCT05350852Unknown1 期
To Evaluate the Safety, Efficacy and Pharmacokinetics of ThisCART19A in Patients With MRD Positive Acute B-cell Leukemia
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
- The incidence of all grade TEAEs and ≥3 grade TEAEs
研究概览
简要总结
This is an open label, phase I study to assess the safety, efficacy and pharmacokinetics of ThisCART19A in patients with MRD+ B-ALL
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •All subjects or legal representatives must sign a voluntary letter of consent approved by the IRB in person prior to the commencement of any screening procedure;
- •Patients diagnosed with B-ALL according to the Chinese Guidelines for the Diagnosis and Treatment of Adult Acute Lymphoblastic Leukemia (2021 edition);
- •There is no gender limitation, age 18-65 (upper limit not included);
- •Disease status ≥CR2 with bone marrow flow cytometry MRD≥0.1%.
- •Patients with Ph+ R/R ALL who failed after 2-line TKI treatment, were intolerant to TKI treatment or were not suitable for TKI treatment;
- •The expected survival time is ≥12 weeks;
- •ECOG score 0-1;
- •Had good organic function during screening
- •CD19 was still expressed on leukemia cells in bone marrow, peripheral blood or biopsy tissue by flow cytometry, results within one month prior to informed consent are acceptable (after the last treatment).
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.
- •< 100 days after hematopoietic stem cell transplantation.
- •Active HBV or HCV or HIV or Syphilis infection. HBV-DNA < 2000 IU/mL can be enrolled, but should admitted to use anti-virus drugs such as entecavir, tenufovir, etc, and supervisory the relative indication during the treatment.
- •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 cleansing (SARS-COV19 can be included, inactivated, live/non-live adjuvant vaccinations allowed to be included) .
- •Patients who are receiving 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.
- •Any ineligibility conditions considered by the investigator that may increase the risk of the subject or interfere with the results of the study.
结局指标
主要结局
The incidence of all grade TEAEs and ≥3 grade TEAEs
时间窗: Up to 2 years after ThisCART19A infusion
Incidence of treatment-emergent adverse events (TEAEs) and ≥3 grade TEAEs
Dose-limiting toxicity (DLT)
时间窗: Up to 28 days after ThisCART19A infusion
DLT is defined as the incidence of severe adverse events related to ThisCART19A more than 33% in each dose level.
次要结局
- Relapse-Free Survival(24 months)
- The change characteristics of chimeric antigen receptor(CAR)-T cell number and copy number in patients after infusion(3 months)
- Changes in immune effect cells count after ThisCART19A infusion.(3 months)
- MRD response rate(At Month 1, 2, 3)
- Changes in cytokine level after ThisCART19A infusion.(3 months)
研究者
He Huang
President/Proffessor
Zhejiang University
研究点 (1)
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