NCT07162571尚未招募1 期
Phase I/II Open-label Study Evaluating The Safety And Efficacy of Anti CD19/22 CAR-T Cells Therapy Adults With R/ R Leukemia/ Lymphoma
Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2026年1月1日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Phase I. Safety
研究概览
简要总结
The purpose of this study is to estimate the safety and the efficacy of anti-CD19/22 CAR- T cells immunotherapy for adults with relapsed or refractory acute lymphoblastic leukemia/lymphoma.
详细描述
Locally manufactured second generation autologous CD19/22 CAR-T cells are used for immunotherapy. Protocol treatment includes leukapheresis in order to harvest T cells, lymphodepleting conditioning (fludarabine + cyclophosphamide) followed by one dual targeting CAR-T cells infusion.
The Main research objectives of the Phase I:
To preliminarily explore the safety (incidence of CRS, ICANS, HLH, infections, late ICAHT, and cytopenias) and tolerability.
The Secondary research objectives of the Phase I:
To explore the pharmacokinetics of CAR-T cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Male or female, aged ≥18 years.
- •Willing and able to give written, informed consent.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to
- •Relapsed or refractory lymphoblastic leukemia/lymphoma.
- •- Chemotherapy-refractory disease after ≥1 lines of therapy
- •- Relapse after chemotherapy or after ASCT/Allo-HSCT.
- •Adequate organ system function including - Creatinine clearance ≥40 cc/min.
- •- Serum alanine aminotransferase / aspartate aminotransferase ≤2.5 x upper limit of normal (ULN).
- •- Total bilirubin ≤1.5 x ULN, except in subjects with Gilbert's syndrome.
- •- Left ventricular ejection fraction (LVEF) ≥50% (by echocardiogram [ECHO] or
- •- Baseline oxygen saturation >92% on room air and ≤Grade 1 dyspnoea.
- •Have no active GVHD (Grade 2-4)
- •Adequate bone marrow (BM) function - Absolute neutrophil count ≥1.0 × 10^9/L.
- •Absolute lymphocyte count ≥0.3 × 10^9/L (at enrolment and prior to leukapheresis).
- •Haemoglobin ≥80 g/L.
- •Platelets ≥75 × 10^9/L
- •7. The expression of CD19 and/or CD22 on the tumor cells are reported as positive by either immunohistochemistry or flow cytometry
排除标准
- •Females who are pregnant or lactating.
- •History or presence of clinically relevant CNS pathology such as epilepsy, paresis, aphasia, stroke within prior 3 months, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, or psychosis.
- •Patients with active CNS involvement by malignancy. Patients with history of central nervous system (CNS) involvement with malignancy may be eligible if CNS disease has been effectively treated and provided treatment was at least 4 weeks prior to enrolment (at least 8 weeks prior to CAR-T infusion).
- •Clinically significant, uncontrolled heart disease or a recent (within 12 months) cardiac event.
- •Active bacterial, viral or fungal infection requiring systemic treatment. Active or latent hepatitis B infection or hepatitis C infection. Testing positive for human immunodeficiency virus, human T cell lymphotropic virus (HTLV1 and 2) or syphilis.
- •History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 24 months.
- •6. Evidence of active pneumonitis on chest computed tomography (CT) scan at screening or history of drug-induced pneumonitis, idiopathic pulmonary fibrosis, organising pneumonia, or idiopathic pneumonitis.
- •7. History of other malignant neoplasms unless disease free for at least 24 months (carcinoma in situ, non-melanoma skin cancer, breast or prostate cancer on hormonal therapy allowed).
- •8. The following medications are excluded:
- •Steroids: Therapeutic doses of corticosteroids within 7 days of leukapheresis or 72 hours prior to CAR-T administration. However, physiological replacement, topical, and inhaled steroids are permitted.
- •Immunosuppression: Immunosuppressive medication must be stopped ≥2 weeks prior to leukapheresis or CAR-T cells infusion.
- •Cytotoxic chemotherapies within 1 week of CAR-T cellsinfusion and 1 week prior to leukapheresis.
- •Antibody therapy use including anti-CD20/19/22 therapy within 2 weeks prior to CAR-T cells infusion.
- •Granulocyte-colony stimulating factor less than 14 days prior to leukapheresis.
- •Live vaccine ≤4 weeks prior to enrolment.
- •Prophylactic intrathecal therapy: Methotrexate within 4 weeks and other intrathecal chemotherapy (e.g. Ara-C) within 2 weeks prior to starting pre-conditioning chemotherapy.
- •Prior limited radiation therapy within 2 weeks of CAR-T cells infusion.
- •Known allergy to albumin, dimethyl sulphoxide (DMSO), cyclophosphamide or fludarabine or tocilizumab.
- •10. Any other condition that in the Investigator's opinion would make the patient unsuitable for the clinical trial.
研究组 & 干预措施
CD19/22 CAR-T cells immunotherapy
Experimental
干预措施: CD19/22 CAR-T cells (Biological)
结局指标
主要结局
Phase I. Safety
时间窗: 1 month post CAR-T cells infusion
Number of Participants With Grade 3-5 Toxicities. Adverse events will be graded according to the CTCAE v5.0
Phase II. Overall response rate
时间窗: 3 months post CAR-T cells infusion
Including complete response (CR) and partial response (PR) rates
次要结局
- Phase I. CAR-T proliferation(3 months post CAR-T cells infusion)
- Phase II. Efficacy: Overall survival rates(12 months post CAR-T cells infusion)
- Phase II. Progression-free survival rates(12 months post CAR-T cells infusion)
- Phase II. Duration of response(12 months post CAR-T cells infusion)
研究者
Mikhail Uss
Dr. Mikhail Uss. Head of the Department of Bone Marrow Transplantation, Researcher
Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
研究点 (1)
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