Solid TumorPhase 1/2NCT05581719
A Phase 1/2a Study Evaluating Allocetra-OTS as Monotherapy or in Combination With Anti-PD-1 Therapy for the Treatment of Advanced Solid Tumor Malignancy
A Phase 1/2 study testing Allocetra-OTS, Nivolumab and Tislelizumab in people with Solid Tumor and Peritoneal Metastases, run by Enlivex Therapeutics RDO Ltd. at 6 sites in 2 countries.
Trial summary
This is an open-label, non-randomized, multicenter, Phase 1/2a study to evaluate the safety and potential efficacy of Allocetra-OTS in the treatment of advanced solid tumor malignancy as monotherapy or in combination with an anti-PD-1 therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Peritoneal Metastases, Peritoneal Cancer
- What is being tested?
- Allocetra-OTS, Nivolumab and Tislelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 15 Nov 2022to 15 Apr 2024
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically or cytologically confirmed locally advanced, unresectable or metastatic solid tumors, that have relapsed or have been refractory to available approved therapies, or patients who are not eligible for or declined additional standard of care systemic therapy.
- Patients with peritoneal carcinomatosis can be eligible if an appropriate IP catheter or port can be placed.
- Patients must have measurable disease.
- Age ≥ 18 years old.
- ECOG performance status ≤1.
- Adequate renal function, hepatic function, and bone marrow function.
Who cannot join
- Primary central nervous system (CNS) malignancy or CNS involvement, unless stable clinically.
- Clinically significant uncontrolled infection, autoimmune or inflammatory diseases requiring systemic immunosuppression, clinically significant cardiovascular disease, severe pulmonary diseases or additional malignancies.
- [For patients in Stage 2] Patients who previously experienced an ICI-related adverse reaction that resulted in discontinuation of the ICI.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Israel4 sites
Rambam Medical Center
Haifa
Hadassah Medical Center
Jerusalem
Sheba Medical Center
Ramat Gan
Sourasky Medical Center
Tel Aviv
About this study
This is an open-label, non-randomized, multicenter, Phase 1/2a study to evaluate the safety and potential efficacy of Allocetra-OTS in the treatment of advanced solid tumor malignancy as monotherapy or in combination with an anti-PD-1 therapy.
Read the detailed description
Despite the advent of novel targeted and immunotherapeutics for the treatment of solid tumors, many patients remain without cure.
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 an open-label, non-randomized, multicenter, Phase 1/2a study to evaluate the safety and potential efficacy of Allocetra-OTS in the treatment of advanced solid tumor malignancy as monotherapy (Stage 1), and in combination with an anti-PD-1 therapy (Stage 2).
Allocetra-OTS will be administered systemically or locally (intravenous [IV] or intraperitoneal [IP]) according to the tumor location.
- Conditions
- Solid Tumor, Peritoneal Metastases, Peritoneal Cancer
- Being tested
- Allocetra-OTS, Nivolumab, Tislelizumab
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.
NivolumabDrug
Immune checkpoint inhibitor (anti-PD-1 antibody)
TislelizumabDrug
Immune checkpoint inhibitor (anti-PD-1 antibody)
| Study group | Role | What they receive |
|---|---|---|
| Stage 1 (Allocetra-OTS monotherapy) | Experimental | Dose escalation of Allocetra-OTS up to 10 x 10^9 cells by IV or IP administration. Receives: Drug: Allocetra-OTS |
| Stage 2.1 (Allocetra-OTS in combination with anti-PD-1 therapy) | Experimental | Dose escalation of Allocetra-OTS up to 10 x 10^9 cells by IV or IP administration, with IV nivolumab 240 mg. Receives: Drug: Allocetra-OTS; Drug: Nivolumab |
| Stage 2.2 (Allocetra-OTS in combination with anti-PD-1 therapy) | Experimental | Dose escalation of Allocetra-OTS up to 10 x 10^9 cells by IV or IP administration, with IV tislelizumab 200 mg. Receives: Drug: Allocetra-OTS; Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Allocetra-OTS
Characterize the safety of Allocetra-OTS based on the dose-limiting toxicities (DLTs) of Allocetra-OTS as monotherapy or in combination with anti-PD1 therapy.
Measured: 3-5 weeks
Secondary outcomes (6)
Overall Response Rate (ORR)/Best Overall Response Rate (BORR)
Overall Response Rate (ORR)/Best Overall Response Rate (BORR) (percentage of patients who achieve best response of complete response [CR] or partial response [PR]).
Measured: 12 months
Clinical benefit rate (CBR)
Clinical benefit rate (CBR) (percentage of patients who achieve best response of CR, PR or stable disease [SD]).
Measured: 12 months
Duration of response (DoR)
Duration of response (DoR), defined as the time from first documented evidence of CR or PR until disease progression or death.
Measured: 12 months
Time to response (TTR)
Time to response (TTR), defined as the time to the first documented CR or PR.
Measured: 12 months
Progression-free survival (PFS)
Progression-free survival (PFS), defined as the time to disease progression or death due to any cause.
Measured: 12 months
Overall survival (OS)
Overall survival (OS) defined as the time to death due to any cause.
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 posted14 Oct 2022
- Study start15 Nov 2022
- Primary completion15 Apr 2024
- Study completion15 Apr 2024
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enlivex Therapeutics RDO Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roni Shapira, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05581719
- Sponsor's protocol ID
- ENX-CL-04-002a
- Status last verified
- Apr 2024
- First submitted
- 12 Oct 2022
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a Study Evaluating Allocetra-OTS as Monotherapy or in Combination With Anti-PD-1 Therapy for the Treatment of Advanced Solid Tumor Malignancy
- ClinicalTrials.gov ID
- NCT05581719
- Acronym / sponsor ID
- ENX-CL-04-002a
- Conditions
- Solid Tumor, Peritoneal Metastases, Peritoneal Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Enlivex Therapeutics RDO Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 14 Oct 2022 (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.
This is an open-label, non-randomized, multicenter, Phase 1/2a study to evaluate the safety and potential efficacy of Allocetra-OTS in the treatment of advanced solid tumor malignancy as monotherapy or in combination with an anti-PD-1 therapy.
Detailed description
Despite the advent of novel targeted and immunotherapeutics for the treatment of solid tumors, many patients remain without cure.
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 an open-label, non-randomized, multicenter, Phase 1/2a study to evaluate the safety and potential efficacy of Allocetra-OTS in the treatment of advanced solid tumor malignancy as monotherapy (Stage 1), and in combination with an anti-PD-1 therapy (Stage 2).
Allocetra-OTS will be administered systemically or locally (intravenous [IV] or intraperitoneal [IP]) according to the tumor location.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stage 1 (Allocetra-OTS monotherapy) | Experimental | Drug: Allocetra-OTSDose escalation of Allocetra-OTS up to 10 x 10^9 cells by IV or IP administration. |
| Stage 2.1 (Allocetra-OTS in combination with anti-PD-1 therapy) | Experimental | Drug: Allocetra-OTS, Drug: NivolumabDose escalation of Allocetra-OTS up to 10 x 10^9 cells by IV or IP administration, with IV nivolumab 240 mg. |
| Stage 2.2 (Allocetra-OTS in combination with anti-PD-1 therapy) | Experimental | Drug: Allocetra-OTS, Drug: TislelizumabDose escalation of Allocetra-OTS up to 10 x 10^9 cells by IV or IP administration, with IV tislelizumab 200 mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must have histologically or cytologically confirmed locally advanced, unresectable or metastatic solid tumors, that have relapsed or have been refractory to available approved therapies, or patients who are not eligible for or declined additional standard of care systemic therapy.
- Patients with peritoneal carcinomatosis can be eligible if an appropriate IP catheter or port can be placed.
- Patients must have measurable disease.
- Age ≥ 18 years old.
- ECOG performance status ≤1.
Key exclusion criteria (3 listed)
- Primary central nervous system (CNS) malignancy or CNS involvement, unless stable clinically.
- Clinically significant uncontrolled infection, autoimmune or inflammatory diseases requiring systemic immunosuppression, clinically significant cardiovascular disease, severe pulmonary diseases or additional malignancies.
- [For patients in Stage 2] Patients who previously experienced an ICI-related adverse reaction that resulted in discontinuation of the ICI.
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. | Drug | Stage 1 (Allocetra-OTS monotherapy), Stage 2.1 (Allocetra-OTS in combination with anti-PD-1 therapy), Stage 2.2 (Allocetra-OTS in combination with anti-PD-1 therapy) |
| NivolumabImmune checkpoint inhibitor (anti-PD-1 antibody) | Drug | Stage 2.1 (Allocetra-OTS in combination with anti-PD-1 therapy) |
| TislelizumabImmune checkpoint inhibitor (anti-PD-1 antibody) | Drug | Stage 2.2 (Allocetra-OTS in combination with anti-PD-1 therapy) |
Primary outcome
Safety of Allocetra-OTS
Time frame: 3-5 weeks
Characterize the safety of Allocetra-OTS based on the dose-limiting toxicities (DLTs) of Allocetra-OTS as monotherapy or in combination with anti-PD1 therapy.
6 secondary outcomes
Overall Response Rate (ORR)/Best Overall Response Rate (BORR)
Time frame: 12 months
Clinical benefit rate (CBR)
Time frame: 12 months
Duration of response (DoR)
Time frame: 12 months
Time to response (TTR)
Time frame: 12 months
Progression-free survival (PFS)
Time frame: 12 months
Overall survival (OS)
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
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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.
Roni Shapira, MD principal investigator
Sheba Medical Center
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Allocetra-OTS, Nivolumab and Tislelizumab in people with Solid Tumor and Peritoneal Metastases, run by Enlivex Therapeutics RDO Ltd. at 6 sites in 2 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 6 inclusion and 3 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: stopped early, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Israel, Spain. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Sponsor decision). Results are not available in the source record.
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?
Safety of Allocetra-OTS (time frame: 3-5 weeks). 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 17 Apr 2024.