EUCTR2021-006556-14-DK进行中（未招募）1 期
CLIC-1901 CAR T-cells for treatment of patients with relapsed/refractory CD19-positive ALL and NHL (DAN-CART 1901) - DAN-CART 1901
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Relapsed/refractory hematologic disease (in peripheral blood, bone marrow or lymph node biopsy by flow cytometry) defined as one of the following:
- •a.CD19 expressing B-cell acute lymphoblastic leukemia (B-ALL) with one of the following:
- •Second or greater bone marrow (BM) relapse.
- •Any relapse after allogeneic haematopoietic stem cell transplantation (HSCT).
- •Primary refractory, defined as not achieving complete remission (CR) after 2 cycles of standard chemotherapy regimen, or chemo refractory, defined as not achieving CR after 1 cycle of standard chemotherapy for relapsed leukemia.
- •Philadelphia chromosome-positive ALL intolerant of or with 2 failed lines of tyrosine kinase inhibitor (TKI) therapy or if TKI therapy is contraindicated.
- •Ineligible for allogeneic HSCT due to comorbidity, contraindications to conditioning regimen, lack of a suitable donor, prior HSCT, or declined allogeneic HSCT after documented detailed discussion of this treatment option with the given patient.
- •b.Histologically confirmed B-cell non-Hodgkin’s lymphoma including diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma, High-grade B cell lymphoma with or without double hit, primary mediastinal large B-cell lymphoma, mantle cell lymphoma, Richter-transformed chronic lymphocytic lymphoma (CLL) or transformed follicular lymphoma with one of the following:
- •Second or greater relapse.
- •Relapse after autologous or allogeneic haematopoietic stem cell transplantation (HSCT).
- •Primary refractory, defined as not achieving partiel remission (PR) at time of interim-scanning or as defined in frontline protocol.
- •2.Age of 1-70 years
- •3.Life expectancy = 12 weeks after enrollment
- •4.Adequate organ function defined as:
- •a.Lansky (<16 years) or Karnofsky (>16 years) score > 50%
- •b.FEV1 or DLCOc = 40 % of expected and oxygen saturation > 90% without oxygen supply
- •c.LVEF > 45% and no symptoms of ischemic heart disease
- •d.Bilirubin < 2 x upper normal limit for age (except for patient diagnosed with Gilbert syndrome)
- •e.ALT < 5 x upper normal limit for age
- •f.EDTA clearance >40mL/min (adults) or >30% of normal limit for age (children)
- •5.Signed statement of consent after receiving oral and written study information
- •6.Agreement to utilize highly effective contraception methods from time of leukapheresis until a minimum of 12 months after CAR-T infusion for all female patients of childbearing potential and all male patients with a female partner of childbearing potential. Highly effective contraception is defined as: total abstinence, female sterilization (oophorectomy, total hysterectomy or tubal ligation), male sterilization or use of oral, injected or implanted hormonal methods of contraception or placement or an intrauterine system/device.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 8
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •oPrior malignancy (except for non-melanoma skin cancer) with on-going evidence of active disease or expected 5-year survival below 50% (as best estimation by treating oncologist)
- •oPatients with concomitant genetic syndrome, such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known familial bone marrow failure syndrome
- •oPrior treatment with any gene therapy product
- •oTreatment with any investigational agent within 30 days prior to enrollment
- •oTreatment with allogeneic haematopoietic stem cell transplantation within 6 months or donor lymphocyte infusion within 6 weeks from CAR-T infusion
- •oAcute or chronic graft-versus-host disease with the need for systemic corticosteroid treatment within 4 weeks prior to enrollment
- •oAcute or chronic infections with HIV
- •oActive infection with, hepatitis B or hepatitis C
- •oActive severe bacterial, viral or fungal infection
- •oActive Central Nervous System (CNS) involvement by malignancy, defined by CNS-3 per NCCN guidelines for ALL, or any evidence of lymphoma on lumbar puncture or brain imaging (if performed).
- •oPre-existing significant central neurological disorder defined as CTCAE grade 3-4 (other than CNS involvement of underlying hematological malignancy)
- •oHistory of anaphylaxis to gentamicin or its derivates
- •oPregnant or breastfeeding women
研究者
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