search
Back to results

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

Primary Purpose

Peritoneal Metastases

Status
Recruiting
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Allocetra-OTS
Sponsored by
Enlivex Therapeutics RDO Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peritoneal Metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Chaim Sheba Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohorts 1-2

Cohorts 3-4

Arm Description

Escalating doses of Allocetra-OTS up to 10 x 10^9 cells.

Allocetra-OTS at the maximal tolerated dose.

Outcomes

Primary Outcome Measures

Number and severity of Allocetra-OTS related adverse events (AEs) and serious adverse events (SAEs)
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

Best Overall Response Rates (BORR)
Best Overall Response Rates (BORR) will be comprised of clinical, radiological and pathology assessments.
Change in specific cancer markers
Change in the specific cancer markers (CEA, CA-19-9, CA-125) from baseline to each post-PIPAC assessment.
Progression-free survival (PFS)
Progression-free survival (PFS) assessed based on imaging data (PET/CT)
Overall Survival (OS)
OS up to 12 months from the first administration of study treatment.
Change in quality of life
Change in quality of life according to EORTC QLQ-CR29 from screening to 16 weeks.

Full Information

First Posted
June 8, 2022
Last Updated
February 26, 2023
Sponsor
Enlivex Therapeutics RDO Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT05431907
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2022 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Enlivex Therapeutics RDO Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohorts 1-2
Arm Type
Experimental
Arm Description
Escalating doses of Allocetra-OTS up to 10 x 10^9 cells.
Arm Title
Cohorts 3-4
Arm Type
Experimental
Arm Description
Allocetra-OTS at the maximal tolerated dose.
Intervention Type
Drug
Intervention Name(s)
Allocetra-OTS
Intervention Description
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 Measure Information:
Title
Number and severity of Allocetra-OTS related adverse events (AEs) and serious adverse events (SAEs)
Description
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.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Best Overall Response Rates (BORR)
Description
Best Overall Response Rates (BORR) will be comprised of clinical, radiological and pathology assessments.
Time Frame
16 weeks
Title
Change in specific cancer markers
Description
Change in the specific cancer markers (CEA, CA-19-9, CA-125) from baseline to each post-PIPAC assessment.
Time Frame
16 weeks
Title
Progression-free survival (PFS)
Description
Progression-free survival (PFS) assessed based on imaging data (PET/CT)
Time Frame
6 months
Title
Overall Survival (OS)
Description
OS up to 12 months from the first administration of study treatment.
Time Frame
12 months
Title
Change in quality of life
Description
Change in quality of life according to EORTC QLQ-CR29 from screening to 16 weeks.
Time Frame
16 weeks
Other Pre-specified Outcome Measures:
Title
Additional Safety Endpoint: Number and severity of related AEs and SAEs throughout 6 months from the first administration of study treatment.
Description
Number and severity of related AEs and SAEs throughout 6 months from the first administration of study treatment.
Time Frame
6 months
Title
Exploratory Endpoint: Change in macrophages and immune cells characteristics in peritoneal fluid
Description
Change in macrophages and immune cells characteristics in peritoneal fluid and tissues from baseline up to 12 weeks.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lital Weinfeld-Bergman
Phone
+97286380305
Email
lital@enlivexpharm.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lior Binder
Phone
+972548054899
Email
lior@enlivexpharm.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avi Nissan, MD
Organizational Affiliation
Department of Surgical Oncology, Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chaim Sheba Medical Center
City
Ramat Gan
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Avi Nissan, MD
Email
Aviram.Nissan@sheba.health.gov.il

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs