NCT05340829Unknown1 期
To Evaluate the Safety, Efficacy, Pharmacokinetics of ThisCART19A in Patients With AIDS Related B Cell Lymphoma/Lympholeukemia
He Huang1 个研究点 分布在 1 个国家目标入组 18 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
- 18
- 试验地点
- 1
- 主要终点
- Dose limited toxicity(DLT) observation and the incidence of treatment-emergent adverse events(TEAE) which more than or equal to grade 3 in each dose level
研究概览
简要总结
This is an open label, phase I study to assess the safety and efficacy of ThisCART19A in patients with AIDS related B cell lymphoma/lympholeukemia.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with AIDS-associated B-cell lymphoma/leukemia, including but not limited to diffuse large B-cell lymphoma (DLBCL), follicular lymphoma tranferring to DLBCL, mantle cell lymphoma (MCL), follicular lymphoma 3B (FL-3B), original Mediastinal (thymus) large B-cell lymphoma, high-grade B-cell lymphoma and leukemia.
- •At least received first line treatment.
- •Had available evaluation lesion.
- •ECOG(Eastern Cooperative Oncology Group) ≤ 1 or Karnofsky ≥ 60%.
- •Had good organic function within 4 weeks before enrollment: Alanine aminotransferase(ALT)≤5×ULN(Upper limit of normal) and total bilirubin(TBIL)<2.0 mg/dL(for patients with Gilbert heald diseases, live involvement and taking atazanavir or indinavir, TBIL<3.0 mg/dL can be enrolled.); Left ventricular ejection fraction(LVEF)≥40%; Absolute neutrophile counts≥1000/mm3; thrombocyte≥30000/mm3; Serum creatinine≤1.5×ULN or creatinine clearance>30 mL/min/1.73 m
- •Confirmed Cluster of differentiation(CD)19 positive by biopsy for the patients who received CD19 target therapy before.
- •Confirmed Human immunodeficiency virus(HIV)-1 infection.
- •HIV virus loading < 200 copy/ml within 4 weeks before screening.
- •CD4+T cell counts >50 cells/mm3 within 4 weeks before screening.
- •Patients with TBIL≤ 1.5 mg/dL, Aspartate aminotransferase(AST) and ALT ≤ 3×ULN, and hepatitis B virus(HBV) DNA <2000 IU/ml can be enrolled for HBV positive patients(defined as hepatitis B virus surface antigen(HBsAg) positive and hepatitis B core(HBc)-total positive ) and hepatitis C virus(HCV) positive patients(defined as HCV antibody positive) . Patients with cirrhosis are excluded.
- •Hepatitis B core antibody(HBcAb) positive patients enrolled in this trial have to taking anti-HBV drugs during the whole research.
排除标准
- •Known for allergic to the preconditioning measures.
- •Uncontrollable bacterial, fungal, viral infection before enrollment.
- •Patients with pulmonary embolism within 3 months prior enrollment.
- •Intolerable serious cardiovascular and cerebrovascular diseases and hereditary diseases.
- •Imaging confirmed the presence of central nervous system involvement(including primary and secondary) and rapid progressing diseases.
- •Receive allogeneic hematopoietic stem cell transplantation.
- •Systemic steroid use (e.g., prednisone ≥20mg) within 3 days prior to screening. iIntermittent use of topical, inhaled or intranasal steroids recently or currently. Or systemic disease requiring long-term use of immunosuppression drugs.
- •Excluded the patients received Influenza vaccinations within 2 weeks prior to lymphodepletion (Received Severe Acute Respiratory Syndrome-Corona virus disease(SARS-COV)19 vaccines could be included. Received inactivated, live/non-live adjuvant vaccines could be enrolled).
- •Excluded women who are in pregnant or lactating, and female subjects or partners who plan to be pregnant within 1 year after infusion. Male subjects planning pregnancy within 1 year after infusion should be excluded.
结局指标
主要结局
Dose limited toxicity(DLT) observation and the incidence of treatment-emergent adverse events(TEAE) which more than or equal to grade 3 in each dose level
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.
次要结局
- The change characteristics of chimeric antigen receptor(CAR)-T cell number and copy number in patients after infusion(6 months)
- Analysis the immunogenicity(Anti-therapeutic antibody and neutralizing antibody) of CAR-T cells in patients after infusion(24 months)
- Analysis the severity and Incidence of Adverse Events in each dose level(12 months)
- Analysis the change characteristics of cytokines and immune effect cells number in patients after infusion(3 months)
- Objective Response rate in patients with AIDS related lymphoma(12 months)
研究者
He Huang
President/Proffessor
Zhejiang University
研究点 (1)
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