Open-label Phase I Study for PEP or Treatment of HS-ARS PLX-R18 for the Post-Exposure Prevention (PEP) or Treatment of Hematopoietic Syndrome of Acute Radiation Syndrome (HS-ARS) (HS-ARS)

July 27, 2020 updated by: Pluristem Ltd.

Open-label Phase I Study to Evaluate the Safety of PLX-R18 for the Post-Exposure Prevention (PEP) or Treatment of Hematopoietic Syndrome of Acute Radiation Syndrome (HS-ARS)

The objective of the study is to evaluate the safety of intramuscular (IM) administration of PLX-R18 in subjects exposed to ionizing radiation and who are at risk of developing HS-ARS.

Indication:Post-Exposure Prevention (PEP) or treatment of Hematopoietic Syndrome of Acute Radiation Syndrome (HS-ARS) in subjects suspected to have been exposed to ionizing radiation.

Study Overview

Status

Unknown

Intervention / Treatment

Detailed Description

This will be a Phase I, open-label safety study; each subject will receive two administrations of PLX-R18, 4 days apart. Each administration of PLX-R18 will contain 4 million cells/kg (up to a maximal dose of 400 million cells). The first administration should be preferably within 48 hours after suspected exposure and no later than 4 days after suspected exposure. The second administration will be provided 4 days after first administration.

All subjects will be hospitalized for at least 24 hours after each administration of PLX-R18,for close monitoring.In order to minimize risks, subjects will be divided in 3 sequential cohorts:

Cohort 1: 9 subjects, treated as soon as possible Cohort 2: 18 subjects, treated at least 12 hours following the first dose administered to the 9th subject Cohort 3: 33 subjects, treated at least 12 hours following the first dose administered to the 27th subject After the completion of each Cohort, stopping rules will be assessed. All subjects will receive PLX-R18 in addition to recommended care per physician discretion, based on the REMM guidelines (APPENDIX 2).

The study will be comprised of 2 periods:

Main study period - Subjects will be followed-up for 12 months and evaluated at the following time points after the first administration: Day 0 (first administration),Day 1, Day 2, Day 3, Day 4 (second administration), Day 5, Day 14 (2 weeks),Day 21 (3 weeks), Day 28 (4 weeks), Day 49 (7 weeks), Day 63 (9 weeks), Day 119(17 weeks), Day 182 (26 weeks), and Day 364 (52 weeks).Long-term survival follow-up -Week 52 to Week 260: During this period, patients will be followed-up for overall survival at: 104 weeks, 156 weeks, 208 weeks and 260 weeks.

Study Type

Interventional

Enrollment (Anticipated)

27

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject was exposed or suspected to have been exposed to ionizing radiation of

    ≥1Gy and is at risk of developing HS-ARS, as assessed by the treating physician, based on REMM guidelines (see APPENDIX 1).

  2. PLX-R18 treatment can be initiated within 4 days of exposure.
  3. Aged ≥18 years.
  4. Has provided informed consent. -

Exclusion Criteria:

  1. Known active malignancy or history of malignancy within 3 years prior to screening except for successfully resected skin basal cell carcinoma or skin squamous cell carcinoma not located at the injection sites.
  2. Known active uncontrolled infection (e.g. viral, fungal, and/or bacterial)
  3. Known active infection with Hepatitis A, B, or C.
  4. Pregnancy.
  5. Known hypersensitivity to: Allogeneic stromal cells, dimethyl sulfoxid (DMSO), human serum albumin, or bovine products.
  6. In the opinion of the Investigator the subject is at high risk of developing severe allergic/hypersensitivity reactions and a resuscitation kit including epinephrine is not at hand.
  7. In the opinion of the treating physician, the subject is unsuitable for participating in the study.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 4 million PLX-R18 cells/kg-up to a maximal dose of 400 million
PLX-R18: Allogeneic ex vivo expanded placental stromal cells
Other Names:
  • PLX-R18

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Any Adverse Reaction
Time Frame: From Week 52 to Week 260 patients will be followed-up for overall survival once a year (every 52 weeks±2 after visit 14)
From Week 52 to Week 260 patients will be followed-up for overall survival once a year (every 52 weeks±2 after visit 14)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovered with no sequelae
Time Frame: From Week 52 to Week 260 patients will be followed-up for overall survival once a year (every 52 weeks±2 after visit 14)
The subject has fully recovered from the AE with no residual effects observable.
From Week 52 to Week 260 patients will be followed-up for overall survival once a year (every 52 weeks±2 after visit 14)
Recovered with sequelae
Time Frame: From Week 52 to Week 260 patients will be followed-up for overall survival once a year (every 52 weeks±2 after visit 14)
The event resolved but the subject has sequelae, which is a condition following a consequence of a disease
From Week 52 to Week 260 patients will be followed-up for overall survival once a year (every 52 weeks±2 after visit 14)
Ongoing AE
Time Frame: From Week 52 to Week 260 patients will be followed-up for overall survival once a year (every 52 weeks±2 after visit 14)
AE is still ongoing
From Week 52 to Week 260 patients will be followed-up for overall survival once a year (every 52 weeks±2 after visit 14)
Overall survival
Time Frame: From Week 52 to Week 260 patients will be followed-up for overall survival once a year (every 52 weeks±2 after visit 14)
Overall survival
From Week 52 to Week 260 patients will be followed-up for overall survival once a year (every 52 weeks±2 after visit 14)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2021

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

December 17, 2018

First Submitted That Met QC Criteria

January 7, 2019

First Posted (ACTUAL)

January 8, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 28, 2020

Last Update Submitted That Met QC Criteria

July 27, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • PLX-R18-ARS-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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