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Phase 1/2 Study Evaluating Safety and Potential Efficacy of Allocetra-OTS Via Pressurized Intra-Peritoneal Aerosol Chemotherapy as Add-on to Standard of Care Chemotherapy for Treatment of Peritoneal Metastasis

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ClinicalTrials.gov Identifier: NCT05431907
Recruitment Status : Not yet recruiting
First Posted : June 24, 2022
Last Update Posted : June 24, 2022
Sponsor:
Information provided by (Responsible Party):
Enlivex Therapeutics Ltd.

Brief Summary:
This is an open-label study to evaluate safety and potential efficacy of Allocetra-OTS in the treatment of patients with peritoneal metastasis as an add-on to the standard of care (SoC) chemotherapy.

Condition or disease Intervention/treatment Phase
Peritoneal Metastases Drug: Allocetra-OTS Phase 1 Phase 2

Detailed Description:

Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) is utilized in patients with malignant dissemination to the peritoneal cavity, for the treatment of peritoneal metastasis that have a high tumor burden or are unresectable, and are unresponsive to systemic therapy.

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.

The study will evaluate the safety and potential efficacy of Allocetra-OTS in the treatment of peritoneal metastasis as an add-on to the standard of care (SoC) chemotherapy. Patients will be treated with escalating doses of Allocetra-OTS as an add-on to the chemotherapy administered via PIPAC, and in addition to systemic chemotherapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/2 Study Evaluating Safety and Potential Efficacy of Allocetra-OTS Via Pressurized Intra-Peritoneal Aerosol Chemotherapy as Add-on to Standard of Care Chemotherapy for Treatment of Peritoneal Metastasis
Estimated Study Start Date : July 1, 2022
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : September 1, 2024

Arm Intervention/treatment
Experimental: Cohorts 1-2
Escalating doses of Allocetra-OTS up to 10 x 10^9 cells.
Drug: Allocetra-OTS
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.

Experimental: Cohorts 3-4
Allocetra-OTS at the maximal tolerated dose.
Drug: Allocetra-OTS
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.




Primary Outcome Measures :
  1. Number and severity of Allocetra-OTS related adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 16 weeks ]
    Number and severity of Allocetra-OTS related adverse events (AEs) and serious adverse events (SAEs) during 16-week period starting from the first administration of study treatment.


Secondary Outcome Measures :
  1. Best Overall Response Rates (BORR) [ Time Frame: 16 weeks ]
    Best Overall Response Rates (BORR) will be comprised of clinical, radiological and pathology assessments.

  2. Change in specific cancer markers [ Time Frame: 16 weeks ]
    Change in the specific cancer markers (CEA, CA-19-9, CA-125) from baseline to each post-PIPAC assessment.

  3. Progression-free survival (PFS) [ Time Frame: 6 months ]
    Progression-free survival (PFS) assessed based on imaging data (PET/CT)

  4. Overall Survival (OS) [ Time Frame: 12 months ]
    OS up to 12 months from the first administration of study treatment.

  5. Change in quality of life [ Time Frame: 16 weeks ]
    Change in quality of life according to EORTC QLQ-CR29 from screening to 16 weeks.


Other Outcome Measures:
  1. Additional Safety Endpoint: Number and severity of related AEs and SAEs throughout 6 months from the first administration of study treatment. [ Time Frame: 6 months ]
    Number and severity of related AEs and SAEs throughout 6 months from the first administration of study treatment.

  2. Exploratory Endpoint: Change in macrophages and immune cells characteristics in peritoneal fluid [ Time Frame: 12 weeks ]
    Change in macrophages and immune cells characteristics in peritoneal fluid and tissues from baseline up to 12 weeks.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older.
  • Diagnosis of peritoneal metastasis due to any primary tumor by histopathology or cytology
  • Possession of unresectable tumors (not eligible for Cytoreductive Surgery / Hyperthermic Intra-Peritoneal Chemoperfusion CRS/HIPEC).
  • Adequate performance status and surgical risk
  • Adequate hematopoietic, hepatic and renal function

Exclusion Criteria:

  • Extraperitoneal disease.
  • Bowel obstruction
  • History of Liver cirrhosis with CHILD PUGH classification of B or C or signs of portal hypertension, portal vein thrombosis.
  • Patient with known New York Heart Association (NYHA) class 3 or 4 symptomatic congestive heart failure, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias.
  • Previous history of organ allograft or stem cell transplantation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05431907


Contacts
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Contact: Odelia Ben Shitrit +972548887609 odelia@enlivexpharm.com
Contact: Lior Binder +972548054899 lior@enlivexpharm.com

Locations
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Israel
The Chaim Sheba Medical Center
Ramat Gan, Israel
Contact: Avi Nissan, MD       Aviram.Nissan@sheba.health.gov.il   
Sponsors and Collaborators
Enlivex Therapeutics Ltd.
Investigators
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Principal Investigator: Avi Nissan, MD Department of Surgical Oncology, Sheba Medical Center
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Responsible Party: Enlivex Therapeutics Ltd.
ClinicalTrials.gov Identifier: NCT05431907    
Other Study ID Numbers: ENX-CL-04-001
First Posted: June 24, 2022    Key Record Dates
Last Update Posted: June 24, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes