A Phase 1/2 interventional study of ETIMS in Multiple Sclerosis, Relapsing-Remitting, sponsored by Universitätsklinikum Hamburg-Eppendorf. Completed. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2015-05-04.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Phase 1/2, Interventional, and Treatment
Open-label, single center, phase I clinical trial to assess the safety, tolerability and preliminary efficacy and in vivo mechanisms of action of i.v. administration of autologous peripheral blood mononuclear cell (PBMC) chemically coupled with a cocktail containing seven immunodominant myelin peptides to which T cell responses are demonstrable in early RR MS patients.
Open-label, single center, phase I dose-escalation study to assess the safety, tolerability and preliminary efficacy and in vivo mechanisms of action of a single infusion of autologous peripheral blood mononuclear cells chemically coupled with seven myelin peptides (MOG1-20, MOG35-55, MBP13-32, MBP83-99, MBP111-129, MBP146-170, and PLP139-154) in Multiple Sclerosis patients who were off-treatment for standard therapies. Neurological, magnetic resonance imaging, laboratory, and immunological examinations were performed to assess the safety, tolerability, and in vivo mechanisms of action of this regimen.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 9 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 403 studies on the registry; 83 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma. This patient receives 1x10\^3 cells.
Biological: ETIMS
The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma. This patient receives 1x10\^5 cells.
Biological: ETIMS
The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma. This patient receives 1x10\^7 cells.
Biological: ETIMS
The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma. This patient receives 1x10\^8 cells.
Biological: ETIMS
The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma. This patient receives 5x10\^8 cells.
Biological: ETIMS
The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma. This patient receives 1x10\^9 cells.
Biological: ETIMS
The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma. This patient receives 2.5x10\^9 cells.
Biological: ETIMS
The drug product consists of autologous peripheral blood mononuclear cells that have been chemically coupled with seven myelin peptides and resuspended in autologous plasma. This patient receives 3x10\^9 cells.
Biological: ETIMS
injection of peptide-coupled PBMC by i.v. infusion
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: 12 months
Number of Adverse Events
Time frame: 3 months after treatment
| Milestone | ETIMS 1x10^3 | ETIMS 1x10^5 | ETIMS 1x10^7 | ETIMS 1x10^8 | ETIMS 5x10^8 | ETIMS 1x10^9 | ETIMS 2.5x10^9 | ETIMS 3x10^9 |
|---|---|---|---|---|---|---|---|---|
| Started | 1 | 1 | 1 | 1 | 1 | 2 | 1 | 1 |
| Completed | 1 | 1 | 1 | 1 | 1 | 2 | 1 | 1 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Results for this outcome have not been posted.
| Number of AE | ETIMS Dose Escalation |
|---|---|
| Number of Adverse Events | 14 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ETIMS 1x10^3 | — | 1/1 (100%) | 1/1 (100%) |
| ETIMS 1x10^5 | — | 0/1 (0%) | 1/1 (100%) |
| ETIMS 1x10^7 | — | 0/1 (0%) | 1/1 (100%) |
| ETIMS 1x10^8 | — | 0/1 (0%) | 1/1 (100%) |
| ETIMS 5x10^8 | — | 0/1 (0%) | 1/1 (100%) |
| ETIMS 1x10^9 | — | 0/2 (0%) | 2/2 (100%) |
| ETIMS 2.5x10^9 | — | 0/1 (0%) | 0/1 (0%) |
| ETIMS 3x10^9 | — | 0/1 (0%) | 0/1 (0%) |
| Event | ETIMS 1x10^3 | ETIMS 1x10^5 | ETIMS 1x10^7 | ETIMS 1x10^8 | ETIMS 5x10^8 | ETIMS 1x10^9 | ETIMS 2.5x10^9 | ETIMS 3x10^9 |
|---|---|---|---|---|---|---|---|---|
| diverticulitis of sigmaGastrointestinal disorders | 1/1 | — | — | — | — | — | — | — |
| Event | ETIMS 1x10^3 | ETIMS 1x10^5 | ETIMS 1x10^7 | ETIMS 1x10^8 | ETIMS 5x10^8 | ETIMS 1x10^9 | ETIMS 2.5x10^9 | ETIMS 3x10^9 |
|---|---|---|---|---|---|---|---|---|
| metallic flavor during infusion of study drugGeneral disorders | 0/1 | 1/1 | 0/1 | 0/1 | 0/1 | 0/2 | 0/1 | 0/1 |
| HeadacheNervous system disorders | 1/1 | 0/1 | 0/1 | 0/1 | 0/1 | 0/2 | 0/1 | 0/1 |
| Common coldInfections and infestations | 0/1 | 0/1 | 0/1 | 1/1 | 1/1 | 0/2 | 0/1 | 0/1 |
| DiarrheaGastrointestinal disorders | 1/1 | 0/1 | 0/1 | 0/1 | 0/1 | 0/2 | 0/1 | 0/1 |
| Irritation of punctured veinInjury, poisoning and procedural complications | 0/1 | 1/1 | 0/1 | 0/1 | 0/1 | 0/2 | 0/1 | 0/1 |
| MigraineNervous system disorders | 0/1 | 1/1 | 0/1 | 0/1 | 0/1 | 0/2 | 0/1 | 0/1 |
| Neck painMusculoskeletal and connective tissue disorders | 0/1 | 0/1 | 1/1 | 0/1 | 0/1 | 0/2 | 0/1 | 0/1 |
| Vision disturbanceNervous system disorders | 0/1 | 0/1 | 1/1 | 0/1 | 0/1 | 0/2 | 0/1 | 0/1 |
| Dysaesthesia/pain in one handNervous system disorders | 0/1 | 0/1 | 1/1 | 0/1 | 0/1 | 0/2 | 0/1 | 0/1 |
| Gastric painGastrointestinal disorders | 0/1 | 0/1 | 0/1 | 0/1 | 1/1 | 0/2 | 0/1 | 0/1 |
| Age, Continuous(years) | ETIMS Dose Escalation |
|---|---|
| Median | 42 (27 to 49) |
| Age, Categorical(Participants) | ETIMS Dose Escalation |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 9 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | ETIMS Dose Escalation |
|---|---|
| Female | 8 |
| Male | 1 |
| Region of Enrollment(participants) | ETIMS Dose Escalation |
|---|---|
| Germany | 9 |
No study locations are listed for this record.
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Universitätsklinikum Hamburg-Eppendorf