CTRI/2022/03/041162进行中（未招募）2 期
A phase 2 study to determine the safety and efficacy of IMN-003A cell therapy in patients with relapsed and refractory CD19 positive B cell malignancies - IMAGINE
Immuneel Therapeutics Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Relapsed / Refractory B-Acute Lymphoblastic Leukaemia
- •1.Age 3 years to 45 years at the time of screening
- •2.Beyond first relapse
- •3.Any relapse 6 months after hematopoietic stem cell transplant (HSCT)
- •4.Primary refractory disease
- •5.Philadelphia positive ALL intolerant of TKI
- •6.Ineligible for allogeneic HSCT
- •7.Declines allogeneic HSCT
- •Relapsed / Refractory B-cell Non-Hodgkin’s Lymphoma
- •1.Age 18 years or older
- •2.Beyond first relapse
- •3.Primary refractory disease
- •4.Post autologous HSCT
- •5.Previous treatment with CD20 monoclonal antibody & anthracycline
- •6.At least one positive lesion on CT/PET scan
- •7.Biopsy proven disease
- •Applicable to all patients
- •1.Documentation of CD19 tumour expression demonstrated in bone marrow or peripheral blood by flow cytometry within 3 months of study entry or on lymph node by immunohistochemistry
- •2.Adequate bone marrow, renal, hepatic, pulmonary & cardiac function
- •3.ECOG performance status of 0 or 1 or Lansky (age <16 years) performance status = 70 at screening
- •Other inclusion criteria apply as per clinical trial protocol.
排除标准
- •Relapsed / Refractory B-Acute Lymphoblastic Leukemia
- •1.Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD) or ongoing immunosuppressants
- •Relapsed / Refractory B-cell Non-Hodgkin’s Lymphoma
- •1.History of Richter’s transformation of CLL
- •2.History of allogeneic stem cell transplantation
- •Applicable to all patients
- •1.Previous treatment with CD19 targeted monoclonal antibody or gene therapy
- •2.Clinically significant active infection
- •3.Current CNS disease or other CNS pathology
研究者
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