SepsisPhase 2NCT04612413
A Phase 2 Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients
A Phase 2 study testing Allocetra-OTS in people with Sepsis and Community-acquired Pneumonia, run by Enlivex Therapeutics Ltd. at 31 sites in 5 countries.
Trial summary
A Phase 2, Multi-Center, Randomized, Placebo-Controlled, Dose-Finding Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sepsis, Community-acquired Pneumonia, Urinary Tract Infections
- What is being tested?
- Allocetra-OTS
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 31 sitesin 5 countries
- Study dates
- 30 Nov 2020to 16 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥18 years and ≤90 years of age.
- Meets Sepsis 3 criteria with a SOFA score ≥5 above pre-admission status
- Sepsis due to infection in at least one of the below organs:
- 3.1. Community-Acquired Pneumonia (CAP). 3.2. Urinary tract infection 3.3. Acute cholecystitis diagnosed by Tokyo criteria 3.4. Acute cholangitis diagnosed by Tokyo criteria 3.5. Other intra-abdominal infections (IAI) 3.6. Skin or soft tissue infection
- Adequate source control
Who cannot join
- Sepsis due to infection other than lung infection, UTI, IAI, skin/soft tissue infection or sepsis patients where site of infection is unclear or unknown.
- On chronic dialysis.
- Patients with acute pancreatitis
- Moribund patients
- Weight <50 kg or >120 kg or BMI >40 kg/m^2.
- SOFA score ≥14 at screening.
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- Patients with nosocomial infection.
- A known malignancy.
- Patients with end-stage disease (unrelated to sepsis)
- Known active symptomatic SARS-CoV-2 or chronic viral infections, such as HBV or HCV, HIV or other chronic infections.
- Chronic respiratory disease.
- Known active upper GI tract ulceration or hepatic dysfunction.
- Known NYHA class IV heart failure or unstable angina, ventricular arrhythmias, acute coronary disease or myocardial infarction.
- Known immunocompromised state or medications known to be immunosuppressive.
- Organ allograft or previous history of stem cell transplantation.
Trial locations and contacts
31 sites in 5 countries.
31 sites in 5 countries
France10 sites
CHU d'Angers
Angers
Vendee Departmental Hospital Center
La Roche-sur-Yon
University Hospital of Limoges
Limoges
CHU de Montpellier
Montpellier
CHU de Nantes
Nantes
Bretonneau Hospital
Paris
Centre Hospitalier Victor Dupouy
Paris
Reims University Hospital Robert Debre
Reims
CHU de Rennes
Rennes
Strasbourg University Hospital
Strasbourg
Spain8 sites
Clinic Barcelona University Hospital
Barcelona
University Hospital Sagrat Cor
Barcelona
Vall d'Hebron
Barcelona
Getafe University Hospital
Getafe
Dr. Josep Trueta University Hospital
Girona
University Hospital Arnau de Vilanova of Lleida
Lleida
General University Hospital Gregorio Maranon
Madrid
University Hospital Joan XXIII of Tarragona
Tarragona
Israel7 sites
Soroka Medical Center
Beersheba
Hillel Yaffe Medical Center
Hadera
Bnai Zion Medical Center
Haifa
Hadassah Ein Kerem Medical Center
Jerusalem
Beilinson Medical Center
Petah Tikva
Ziv Medical Center
Safed
Poriya Medical Center
Tiberias
Belgium4 sites
Clinique Saint-Pierre
Brussels
Saint-Luc Hospital University
Brussels
CHU de Charleroi
Charleroi
Ziekenhuis Oost-Limburg
Genk
Netherlands2 sites
Canisius Wilhelmina Hospital
Nijmegen
Radboud UMC
Nijmegen
About this study
Official title: A Phase 2, Multi-Center, Randomized, Placebo-Controlled, Dose-Finding Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients
A Phase 2, Multi-Center, Randomized, Placebo-Controlled, Dose-Finding Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients
Read the detailed description
Allocetra-OTS is an immunomodulatory cell-based therapy consisting of allogeneic peripheral blood mononuclear cells that have been modified to be engulfed by macrophages and reprogram them into their homeostatic state.
This is a multi-center, randomized, placebo-controlled, dose-finding study comparing the efficacy, safety and tolerability of different dosing regimens of Allocetra-OTS, in patients with sepsis. The study aims to compare the safety and efficacy of different doses and regimens of Allocetra-OTS, as well as the clinical manifestations following Allocetra-OTS treatment, to that of Placebo in the treatment of organ failure in adult sepsis patients.
- Conditions
- Sepsis, Community-acquired Pneumonia, Urinary Tract Infections, Cholecystitis, Acute, Cholangitis Acute, Intraabdominal Infections
- Being tested
- Allocetra-OTS, Placebo
- Medical subject headings
- Sepsis, Community-Acquired Pneumonia, Urinary Tract Infections, Cholecystitis, Acute, Intraabdominal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allocetra-OTSDrug
Allocetra-OTS is a cell-based therapy consisting of non-HLA-matched allogeneic peripheral blood mononuclear cells, derived from a healthy human donor following a leukapheresis procedure, induced to an apoptotic stable state and suspended in a solution containing DMSO.
PlaceboOther
Solution containing all excipients except for the Allocetra-OTS cells
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Placebo comparator | Single IV dose of placebo solution Receives: Other: Placebo |
| Cohort 2 | Experimental | Single IV dose of 5x10^9 Allocetra-OTS cells in suspension Receives: Drug: Allocetra-OTS |
| Cohort 3 | Experimental | Single IV dose of 10x10^9 Allocetra-OTS cells in suspension Receives: Drug: Allocetra-OTS |
| Cohort 4 | Experimental | Single or two doses of 10x10^9 Allocetra-OTS cells in suspension Receives: Drug: Allocetra-OTS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Change from baseline in SOFA score
Change from baseline in SOFA score throughout 28 days
Measured: 28 days
Safety: Number and severity of AEs and SAEs
Number and severity of AEs and SAEs throughout 28 days follow up period
Measured: 28 days
Secondary outcomes (9)
Ventilator-free days
Ventilator-free days over 28 days
Measured: 28 days
Vasopressor-free days
Vasopressor-free days over 28 days.
Measured: 28 days
Days without renal replacement therapy (dialysis).
Days without renal replacement therapy (dialysis).
Measured: 28 days
Time in ICU and time in hospital
Time in ICU and time in hospital
Measured: 28 days
Number of days with creatinine ≤ Baseline levels +20%
Number of days with creatinine ≤ Baseline levels +20%
Measured: 28 days
All-cause mortality
All-cause mortality at Day 28 following first dose
Measured: 28 days
Changes from baseline in CRP levels
Changes from baseline in CRP levels
Measured: 28 days
Number and severity of AEs and Serious Adverse Events (SAEs)
Number and severity of AEs and Serious Adverse Events (SAEs) throughout 12 months follow up period
Measured: 12 months
Detection of autoimmune and human leukocyte antigen (HLA) antibodies
Detection of autoimmune and human leukocyte antigen (HLA) antibodies
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start30 Nov 2020
- Primary completion12 Jan 2024
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Up to Protocol Version 10.0, eligible patients were randomized to one of the 4 treatment groups in a 1:1:1:1 ratio between the 4 Cohorts: 1. Placebo 2. Single Intravenous (IV) dose of Allocetra-OTS, 5x10\^9 cells 3. Single IV dose of Allocetra-OTS, 10x10\^9 cells 4. Single or two IV doses of Allocetra-OTS, 10x10\^9 cells in each dose Starting from Protocol Version 10.0, patient will be randomized to either Cohort 1 (Placebo) or Cohort 4 (Single or two IV doses of Allocetra-OTS, 10x10\^9 cells in each dose).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enlivex Therapeutics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pierre Singer, MD, Principal investigator, Rabin medical center, Belinson Campus, Petah Tiqwa Isarel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612413
- Sponsor's protocol ID
- ENX-CL-02-002
- Status last verified
- Aug 2025
- First submitted
- 26 Oct 2020
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multi-Center, Randomized, Placebo-Controlled, Dose-Finding Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients
- ClinicalTrials.gov ID
- NCT04612413
- Acronym / sponsor ID
- ENX-CL-02-002
- Conditions
- Sepsis, Community-acquired Pneumonia, Urinary Tract Infections, Cholecystitis, Acute, Cholangitis Acute, Intraabdominal Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Enlivex Therapeutics Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 12 Jan 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 3 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 2, Multi-Center, Randomized, Placebo-Controlled, Dose-Finding Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients
Detailed description
Allocetra-OTS is an immunomodulatory cell-based therapy consisting of allogeneic peripheral blood mononuclear cells that have been modified to be engulfed by macrophages and reprogram them into their homeostatic state.
This is a multi-center, randomized, placebo-controlled, dose-finding study comparing the efficacy, safety and tolerability of different dosing regimens of Allocetra-OTS, in patients with sepsis. The study aims to compare the safety and efficacy of different doses and regimens of Allocetra-OTS, as well as the clinical manifestations following Allocetra-OTS treatment, to that of Placebo in the treatment of organ failure in adult sepsis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Up to Protocol Version 10.0, eligible patients were randomized to one of the 4 treatment groups in a 1:1:1:1 ratio between the 4 Cohorts: 1. Placebo 2. Single Intravenous (IV) dose of Allocetra-OTS, 5x10^9 cells 3. Single IV dose of Allocetra-OTS, 10x10^9 cells 4. Single or two IV doses of Allocetra-OTS, 10x10^9 cells in each dose Starting from Protocol Version 10.0, patient will be randomized to either Cohort 1 (Placebo) or Cohort 4 (Single or two IV doses of Allocetra-OTS, 10x10^9 cells in each dose).
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Placebo comparator | Other: PlaceboSingle IV dose of placebo solution |
| Cohort 2 | Experimental | Drug: Allocetra-OTSSingle IV dose of 5x10^9 Allocetra-OTS cells in suspension |
| Cohort 3 | Experimental | Drug: Allocetra-OTSSingle IV dose of 10x10^9 Allocetra-OTS cells in suspension |
| Cohort 4 | Experimental | Drug: Allocetra-OTSSingle or two doses of 10x10^9 Allocetra-OTS cells in suspension |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female ≥18 years and ≤90 years of age.
- Meets Sepsis 3 criteria with a SOFA score ≥5 above pre-admission status
- Sepsis due to infection in at least one of the below organs:
- 3.1. Community-Acquired Pneumonia (CAP). 3.2. Urinary tract infection 3.3. Acute cholecystitis diagnosed by Tokyo criteria 3.4. Acute cholangitis diagnosed by Tokyo criteria 3.5. Other intra-abdominal infections (IAI) 3.6. Skin or soft tissue infection
- Adequate source control
Key exclusion criteria (15 listed)
- Sepsis due to infection other than lung infection, UTI, IAI, skin/soft tissue infection or sepsis patients where site of infection is unclear or unknown.
- On chronic dialysis.
- Patients with acute pancreatitis
- Moribund patients
- Weight <50 kg or >120 kg or BMI >40 kg/m^2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allocetra-OTSAllocetra-OTS is a cell-based therapy consisting of non-HLA-matched allogeneic peripheral blood mononuclear cells, derived from a healthy human donor following a leukapheresis procedure, induced to an apoptotic stable state and suspended in a solution containing DMSO. | Drug | Cohort 2, Cohort 3, Cohort 4 |
| PlaceboSolution containing all excipients except for the Allocetra-OTS cells | Other | Cohort 1 |
Primary outcome
Efficacy: Change from baseline in SOFA score
Time frame: 28 days
Change from baseline in SOFA score throughout 28 days
Safety: Number and severity of AEs and SAEs
Time frame: 28 days
Number and severity of AEs and SAEs throughout 28 days follow up period
9 secondary outcomes
Ventilator-free days
Time frame: 28 days
Vasopressor-free days
Time frame: 28 days
Days without renal replacement therapy (dialysis).
Time frame: 28 days
Time in ICU and time in hospital
Time frame: 28 days
Number of days with creatinine ≤ Baseline levels +20%
Time frame: 28 days
All-cause mortality
Time frame: 28 days
Changes from baseline in CRP levels
Time frame: 28 days
Number and severity of AEs and Serious Adverse Events (SAEs)
Time frame: 12 months
Detection of autoimmune and human leukocyte antigen (HLA) antibodies
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Singer, MD principal investigator
Rabin medical center, Belinson Campus, Petah Tiqwa Isarel
31 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Allocetra-OTS in people with Sepsis and Community-acquired Pneumonia, run by Enlivex Therapeutics Ltd. at 31 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in France, Spain, Israel, Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: Change from baseline in SOFA score (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.