Clinical trial NCT01570283: ARMS - Rapidly Generated Multivirus-Specific CTLs for Prophylaxis & Treatment of EBV, CMV, Adenovirus, HHV6 & BK Virus
Official title: ARMS - Administration Of Rapidly Generated Multivirus-Specific Cytotoxic T-Lymphocytes For The Prophylaxis And Treatment Of EBV, CMV, Adenovirus, HHV6, And BK Virus Infections Post Allogeneic Stem Cell Transplant
Conditions: Viral Infection
Summary: The subjects eligible for this trial have a type of blood cell cancer, other blood disease or a genetic disease for which they will receive a stem cell transplant. The donor of the stem cells will be either the subject's brother or sister, or another relative, or a closely matched unrelated donor. The Investigators are asking subjects to participate in this study which tests if blood cells from the subject's donor that have been grown in a special way, can prevent or be a effective treatment for early infection by five viruses - Epstein Barr virus (EBV), cytomegalovirus (CMV), adenovirus, BK virus (BKV) and human herpes virus 6 (HHV6).
The Investigators have grown T cells from the subject's stem cell donor in the laboratory in a way that will train them to recognize the viruses and control them when the T cells are given after a transplant. This treatment with specially trained T cells (also called cytotoxic T cells or "CTLs") has had activity against three of these viruses (CMV, EBV and Adenovirus) in previous studies. In this study the Investigators want to see if they increase the number of viruses that can be targeted to include BKV and HHV6 using a simple and fast approach to make the cells.
The Investigators want to see if they can use a kind of white blood cell called T lymphocytes (or T cells) to prevent and treat adenovirus, CMV, EBV, BKV and HHV6 in the early stages of reactivation or infection.
Interventions:
description: The feasibility and safety of 3 different dose levels will be evaluated and will determine the maximum tolerated dose (MTD) level.<br/>Dose Level One: 5x10^6 mCTLs/m2<br/>There may be an option of administering 2 additional doses (at the same level the patient was receiving), 28 days after the first dose, in subjects that have a partial response after one dose or who receive other therapy that may affect the persistence or function of the infused CTL.
name: Multivirus-specific T cells Dose Level 1
type: Biological
description: The feasibility and safety of 3 different dose levels will be evaluated and will determine the maximum tolerated dose (MTD) level.<br/>Dose Level Two: 1x10^7 mCTLs/m2<br/>There may be an option of administering 2 additional doses (at the same level the patient was receiving), 28 days after the first dose, in subjects that have a partial response after one dose or who receive other therapy that may affect the persistence or function of the infused CTL
name: Multivirus-specific T cells Dose Level 2
type: Biological
description: The feasibility and safety of 3 different dose levels will be evaluated and will determine the maximum tolerated dose (MTD) level.<br/>Dose Level Three: 2x10^7 mCTLs/m2<br/>There may be an option of administering 2 additional doses (at the same level the patient was receiving), 28 days after the first dose, in subjects that have a partial response after one dose or who receive other therapy that may affect the persistence or function of the infused CTL
name: Multivirus-specific T cells Dose Level 3
type: Biological
Study arms:
design_group_description: Cohort 1 prophylaxis: Participants were administrated 5*10^6 mCTLs/m multivirusspecific T cells intravenously for prophylaxis of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
design_group_title: Multivirus-specific T cells 5*10^6 mCTLs/m2 for Prophylaxis
design_group_type: Experimental
design_group_description: Cohort 1 treatment: Participants were administrated 5*10^6 mCTLs/m multivirusspecific T cells intravenously for treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
design_group_title: Multivirus-specific T cells 5*10^6 mCTLs/m2 for Treatment
design_group_type: Experimental
design_group_description: Cohort 2 prophylaxis: Participants were administrated 1*10^7 mCTLs/m multivirusspecific T cells intravenously for prophylaxis of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
design_group_title: Multivirus-specific T cells 1*10^7 mCTLs/m2 for Prophylaxis
design_group_type: Experimental
design_group_description: Cohort 2 treatment: Participants were administrated 1*10^7 mCTLs/m multivirusspecific T cells intravenously for treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
design_group_title: Multivirus-specific T cells 1*10^7 mCTLs/m2 for Treatment
design_group_type: Experimental
design_group_description: Cohort 3 prophylaxis: Participants were administrated 2*10^7 mCTLs/m multivirusspecific T cells intravenously for prophylaxis of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
design_group_title: Multivirus-specific T Cells 2*10^7 mCTLs/m2 for Prophylaxis
design_group_type: Experimental
design_group_description: Cohort 3 treatment: Participants were administrated 2*10^7 mCTLs/m multivirusspecific T cells intravenously for treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
design_group_title: Multivirus-specific T Cells 2*10^7 mCTLs/m2 for Treatment
design_group_type: Experimental
Sponsor: AlloVir, Inc.
Collaborators: Center For Cell & Gene Therapy
Baylor College of Medicine
The Methodist Hospital Research Institute
Drug name mappings:
name: Multivirus-specific cytotoxic T lymphocytes (AlloVir)
lang: EN