NCT04659304

Study Evaluating Safety and Tolerability of Allocetra-OTS in Patients With COVID-19

A Multi-Center , Sequential Dose Escalation Study, Evaluating Safety and Tolerability of Allocetra-OTS in Patients With COVID-19

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Enlivex Therapeutics Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	Allocetra-OTS	Cell-based therapy comprised of allogeneic non-HLA matched peripheral blood mononuclear cells induced to an early apoptotic state.

Timeline

• Start date: 2021-12-01
• Primary completion: 2022-09-01
• Completion: 2022-12-01
• First posted: 2020-12-09
• Last updated: 2021-08-18