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临床试验/NCT01660607
NCT01660607已完成1 期

Phase 1-2 Trial for Patients With Advanced Hematologic Malignancies Undergoing Myeloablative Allogeneic HCT With a T-cell Depleted Graft With Infusion of Conventional T-cells and Regulatory T-cells

Stanford University1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2012年2月9日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
68
试验地点
1
主要终点
GvHD Free Relapse Free Survival (GRFS)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study looks at giving specific types of immune cells, called regulatory T cells and conventional T cells, to patients with blood cancers who are receiving a stem cell transplant. These cells are added back to help the immune system recover and reduce complications after the transplant.

详细描述

Primary Objectives:

  • To determine the efficacy, safety and feasibility of administration of several dose combinations of conventional T cells (Tcon) and regulatory T cells (Treg) in patients undergoing allogeneic hematopoietic cell transplantation (HCT) with HLA matched donors (related or unrelated) using a T cell depleted graft [CD34+ hematopoietic progenitor cells ("CD34+ HSPC")], without immune suppression.
  • To determine if concomitant single-agent immunosuppression is needed with fresh Treg cells (phase 2 stage 1) * To determine 1-year GvHD-free relapse-free survival (GRFS) post-HCT (phase 2 stage 2).

Secondary Objectives:

  • To determine the 1 year OS in patients undergoing allogeneic HCT with matched donors.
  • To measure the incidence and severity of acute and chronic graft vs host disease (GvHD)
  • To measure incidence of serious infections

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
13 Years 至 73 Years（Child, Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Cohort 1, Phase I: Low Dose Treg + Tcon (Dose escalation)

Experimental

Participants receive low-dose Treg (1e6 cells/kg) and Tcon (3e6 cells/kg) with CD34+ HSPC.

干预措施: CD34+ Hematopoietic Progenitor Cells (HSPC) (Biological)

Cohort 1, Phase I: Low Dose Treg + Tcon (Dose escalation)

Experimental

Participants receive low-dose Treg (1e6 cells/kg) and Tcon (3e6 cells/kg) with CD34+ HSPC.

干预措施: Regulatory T-Cells (Treg) (Biological)

Cohort 1, Phase I: Low Dose Treg + Tcon (Dose escalation)

Experimental

Participants receive low-dose Treg (1e6 cells/kg) and Tcon (3e6 cells/kg) with CD34+ HSPC.

干预措施: Conventional T-Cells (Tcon) (Biological)

Cohort 1A, Phase I: Low Dose Treg + Tcon (Dose escalation)

Experimental

Participants receive low-dose Treg (1e6 cells/kg) and Tcon (1e6 cells/kg) with CD34+ HSPC.

干预措施: CD34+ Hematopoietic Progenitor Cells (HSPC) (Biological)

Cohort 1A, Phase I: Low Dose Treg + Tcon (Dose escalation)

Experimental

Participants receive low-dose Treg (1e6 cells/kg) and Tcon (1e6 cells/kg) with CD34+ HSPC.

干预措施: Regulatory T-Cells (Treg) (Biological)

Cohort 1A, Phase I: Low Dose Treg + Tcon (Dose escalation)

Experimental

Participants receive low-dose Treg (1e6 cells/kg) and Tcon (1e6 cells/kg) with CD34+ HSPC.

干预措施: Conventional T-Cells (Tcon) (Biological)

Cohort 2, Phase 1: Mid Dose Treg + Tcon (Dose escalation)

Experimental

Participants receive low-dose Treg (3e6 cells/kg), Tcon (1e6 cells/kg), and CD34+ HSPC following a conditioning regimen.

干预措施: CD34+ Hematopoietic Progenitor Cells (HSPC) (Biological)

Cohort 2, Phase 1: Mid Dose Treg + Tcon (Dose escalation)

Experimental

Participants receive low-dose Treg (3e6 cells/kg), Tcon (1e6 cells/kg), and CD34+ HSPC following a conditioning regimen.

干预措施: Regulatory T-Cells (Treg) (Biological)

Cohort 2, Phase 1: Mid Dose Treg + Tcon (Dose escalation)

Experimental

Participants receive low-dose Treg (3e6 cells/kg), Tcon (1e6 cells/kg), and CD34+ HSPC following a conditioning regimen.

干预措施: Conventional T-Cells (Tcon) (Biological)

Cohort 2, Phase 1: Mid Dose Treg + Tcon (Dose escalation)

Experimental

Participants receive low-dose Treg (3e6 cells/kg), Tcon (1e6 cells/kg), and CD34+ HSPC following a conditioning regimen.

干预措施: Myeloablative Conditioning Regimen (Procedure)

Cohort 2A, Phase I: Mid Dose Treg + Tcon (Dose escalation)

Active Comparator

Participants receive low-dose Treg (up to 3e6 cells/kg), Tcon (3e6 cells/kg), and CD34+ HSPC following a conditioning regimen.

干预措施: CD34+ Hematopoietic Progenitor Cells (HSPC) (Biological)

Cohort 2A, Phase I: Mid Dose Treg + Tcon (Dose escalation)

Active Comparator

Participants receive low-dose Treg (up to 3e6 cells/kg), Tcon (3e6 cells/kg), and CD34+ HSPC following a conditioning regimen.

干预措施: Regulatory T-Cells (Treg) (Biological)

Cohort 2A, Phase I: Mid Dose Treg + Tcon (Dose escalation)

Active Comparator

Participants receive low-dose Treg (up to 3e6 cells/kg), Tcon (3e6 cells/kg), and CD34+ HSPC following a conditioning regimen.

干预措施: Conventional T-Cells (Tcon) (Biological)

Cohort 2A, Phase I: Mid Dose Treg + Tcon (Dose escalation)

Active Comparator

Participants receive low-dose Treg (up to 3e6 cells/kg), Tcon (3e6 cells/kg), and CD34+ HSPC following a conditioning regimen.

干预措施: Myeloablative Conditioning Regimen (Procedure)

Cohort 3, Phase I: High Dose Treg + Tcon (Dose escalation)

Experimental

Participants receive high-dose Treg (3e6 cells/kg), Tcon (3e6 cells/kg), and CD34+ HSPC following a conditioning regimen.

干预措施: CD34+ Hematopoietic Progenitor Cells (HSPC) (Biological)

Cohort 3, Phase I: High Dose Treg + Tcon (Dose escalation)

Experimental

Participants receive high-dose Treg (3e6 cells/kg), Tcon (3e6 cells/kg), and CD34+ HSPC following a conditioning regimen.

干预措施: Regulatory T-Cells (Treg) (Biological)

Cohort 3, Phase I: High Dose Treg + Tcon (Dose escalation)

Experimental

Participants receive high-dose Treg (3e6 cells/kg), Tcon (3e6 cells/kg), and CD34+ HSPC following a conditioning regimen.

干预措施: Conventional T-Cells (Tcon) (Biological)

Cohort 3, Phase I: High Dose Treg + Tcon (Dose escalation)

Experimental

Participants receive high-dose Treg (3e6 cells/kg), Tcon (3e6 cells/kg), and CD34+ HSPC following a conditioning regimen.

干预措施: Myeloablative Conditioning Regimen (Procedure)

Cohort 3A, Phase I: High Dose Treg + Tcon (Dose escalation)

Experimental

Participants receive high-dose Treg (1e6 cells/kg), Tcon (1e6 cells/kg), and CD34+ HSPC following a conditioning regimen.

干预措施: CD34+ Hematopoietic Progenitor Cells (HSPC) (Biological)

Cohort 3A, Phase I: High Dose Treg + Tcon (Dose escalation)

Experimental

Participants receive high-dose Treg (1e6 cells/kg), Tcon (1e6 cells/kg), and CD34+ HSPC following a conditioning regimen.

干预措施: Regulatory T-Cells (Treg) (Biological)

Cohort 3A, Phase I: High Dose Treg + Tcon (Dose escalation)

Experimental

Participants receive high-dose Treg (1e6 cells/kg), Tcon (1e6 cells/kg), and CD34+ HSPC following a conditioning regimen.

干预措施: Conventional T-Cells (Tcon) (Biological)

Cohort 3A, Phase I: High Dose Treg + Tcon (Dose escalation)

Experimental

Participants receive high-dose Treg (1e6 cells/kg), Tcon (1e6 cells/kg), and CD34+ HSPC following a conditioning regimen.

干预措施: Myeloablative Conditioning Regimen (Procedure)

Phase 2: Myeloablative HCT Control

Active Comparator

Participants receive standard myeloablative conditioning with CD34+ HSPC and no experimental Treg or Tcon.

干预措施: CD34+ Hematopoietic Progenitor Cells (HSPC) (Biological)

Phase 2: Myeloablative HCT Control

Active Comparator

Participants receive standard myeloablative conditioning with CD34+ HSPC and no experimental Treg or Tcon.

干预措施: Myeloablative Conditioning Regimen (Procedure)

Phase 2 Treg + Tcon with Immunosuppression

Experimental

Participants receive Treg and Tcon therapy with immunosuppressive drugs following myeloablative conditioning.

干预措施: CD34+ Hematopoietic Progenitor Cells (HSPC) (Biological)

Phase 2 Treg + Tcon with Immunosuppression

Experimental

Participants receive Treg and Tcon therapy with immunosuppressive drugs following myeloablative conditioning.

干预措施: Regulatory T-Cells (Treg) (Biological)

Phase 2 Treg + Tcon with Immunosuppression

Experimental

Participants receive Treg and Tcon therapy with immunosuppressive drugs following myeloablative conditioning.

干预措施: Conventional T-Cells (Tcon) (Biological)

Phase 2 Treg + Tcon with Immunosuppression

Experimental

Participants receive Treg and Tcon therapy with immunosuppressive drugs following myeloablative conditioning.

干预措施: Myeloablative Conditioning Regimen (Procedure)

Phase 2 Treg + Tcon without Immunosuppression

Experimental

Participants receive Treg and Tcon therapy without immunosuppressive drugs following myeloablative conditioning.

干预措施: CD34+ Hematopoietic Progenitor Cells (HSPC) (Biological)

Phase 2 Treg + Tcon without Immunosuppression

Experimental

Participants receive Treg and Tcon therapy without immunosuppressive drugs following myeloablative conditioning.

干预措施: Regulatory T-Cells (Treg) (Biological)

Phase 2 Treg + Tcon without Immunosuppression

Experimental

Participants receive Treg and Tcon therapy without immunosuppressive drugs following myeloablative conditioning.

干预措施: Conventional T-Cells (Tcon) (Biological)

Phase 2 Treg + Tcon without Immunosuppression

Experimental

Participants receive Treg and Tcon therapy without immunosuppressive drugs following myeloablative conditioning.

干预措施: Myeloablative Conditioning Regimen (Procedure)

结局指标

主要结局

GvHD Free Relapse Free Survival (GRFS)

时间窗: 12 months

GvHD-free is defined as no GvHD symptoms, and relapse free survival is defined as survival at 12 months without relapse.

次要结局

  • Number of Participants With Dose-Limiting Toxicity (DLT) Within 28 Days(28 days)
  • Number of Participants With Overall Survival (OS) at 1 Year(1 year)
  • Number of Participants With Severity of Chronic Graft-vs-Host Disease (cGvHD) at 24 Months(2 years)
  • Number of Participants With Incidence of Serious Infections(24 months)
  • Number of Participants Receiving Concomitant Single-Agent Immunosuppression(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Everett Meyer

Associate Professor of Medicine

Stanford University

研究点 (1)

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