Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-03-02 @ 4:55 PM
Study NCT ID:
NCT04659304
Status:
UNKNOWN
Last Update Posted:
2021-08-18
First Post:
2020-12-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating Safety and Tolerability of Allocetra-OTS in Patients With COVID-19
Sponsor:
Enlivex Therapeutics Ltd.
Organization:
Study Overview
Official Title:
A Multi-Center , Sequential Dose Escalation Study, Evaluating Safety and Tolerability of Allocetra-OTS in Patients With COVID-19
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase 1b, multi-center, open label, sequential dose escalation trial assessing 3 dose cohorts using a 3+3 design to evaluate safety and tolerability of Allocetra-OTS in adult patients with moderate COVID-19. The sample size for this trial is anticipated to range from 9 to 18 patients.
Detailed Description:
Potential patients, who will be identified as suffering from moderate COVID-19 (as set forth in the FDA guidance for industry dated May 2020) will be recruited.
After the patient has signed the Informed Consent Form (ICF), and after confirmation that the patient meets all eligibility criteria, the patient will be enrolled to the relevant dose group according to the following sequential design:
Single Intravenous (IV) dose of Allocetra-OTS with 5x10\^9 cells, Single Intravenous (IV) dose of Allocetra-OTS with 10x10\^9 cells, Two IV doses of Allocetra-OTS with10x10\^9 cells each dose (separated by 72 hours).
Each dose cohort will consist of 3 and up to 6 patients. In each dose cohort, starting with dose cohort 1, a single patient will be enrolled and dosed. If no dose limiting toxicity (DLT) is observed after at least 1 week and following review of relevant safety data of the first patient in that cohort by the DMC, 2 additional patients will be enrolled.
If no DLT is seen in the initial 3 dosed patients within a certain cohort and following DMC review, the first patient in the next dose cohort can be enrolled, repeating the same sequence of enrollment as described above.
If 1 DLT is seen in the initial 3 dosed patients within a certain cohort, the cohort will be expanded to a total of 6 patients. If \>2/6 patients experience a DLT, the MTD will be reached. If no more than 1 patient out of 6 experiences a DLT, the next sequence of enrollment will be continued.
DMC will review and assess safety data at the predefined timepoints to recommend on cohort expansion or cohort escalation.
Investigational Product (IP) administration will occur on Day 1 within 12±4 hours from the time of eligibility.
Following IP administration (Day 1), patients will be followed for safety and efficacy assessments through 6 months.
After the patient has signed the Informed Consent Form (ICF), and after confirmation that the patient meets all eligibility criteria, the patient will be enrolled to the relevant dose group according to the following sequential design:
Single Intravenous (IV) dose of Allocetra-OTS with 5x10\^9 cells, Single Intravenous (IV) dose of Allocetra-OTS with 10x10\^9 cells, Two IV doses of Allocetra-OTS with10x10\^9 cells each dose (separated by 72 hours).
Each dose cohort will consist of 3 and up to 6 patients. In each dose cohort, starting with dose cohort 1, a single patient will be enrolled and dosed. If no dose limiting toxicity (DLT) is observed after at least 1 week and following review of relevant safety data of the first patient in that cohort by the DMC, 2 additional patients will be enrolled.
If no DLT is seen in the initial 3 dosed patients within a certain cohort and following DMC review, the first patient in the next dose cohort can be enrolled, repeating the same sequence of enrollment as described above.
If 1 DLT is seen in the initial 3 dosed patients within a certain cohort, the cohort will be expanded to a total of 6 patients. If \>2/6 patients experience a DLT, the MTD will be reached. If no more than 1 patient out of 6 experiences a DLT, the next sequence of enrollment will be continued.
DMC will review and assess safety data at the predefined timepoints to recommend on cohort expansion or cohort escalation.
Investigational Product (IP) administration will occur on Day 1 within 12±4 hours from the time of eligibility.
Following IP administration (Day 1), patients will be followed for safety and efficacy assessments through 6 months.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: