A Phase 1/2a Study Evaluating Allocetra-OTS as Monotherapy or in Combination With Anti-PD-1 Therapy for the Treatment of Advanced Solid Tumor Malignancy

Sponsor
Enlivex Therapeutics RDO Ltd.
Study ID
NCT05581719
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Peritoneal Cancer
  • Peritoneal Metastases
  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Allocetra-OTS — DRUG
    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.
  • Nivolumab — DRUG
    Immune checkpoint inhibitor (anti-PD-1 antibody)
  • Tislelizumab — DRUG
    Immune checkpoint inhibitor (anti-PD-1 antibody)

Study Details

This is an open-label, non-randomized, multicenter, Phase 1/2a study to evaluate the safety and potential efficacy of Allocetra-OTS in the treatment of advanced solid tumor malignancy as monotherapy or in combination with an anti-PD-1 therapy.

Key Dates

First listed
Oct 14, 2022
Start date
Nov 15, 2022
Status verified
Apr 2024
Primary completion
Apr 15, 2024
Completion
Apr 15, 2024

Study Design

Enrollment
14 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Stage 1 (Allocetra-OTS monotherapy)
    Dose escalation of Allocetra-OTS up to 10 x 10\^9 cells by IV or IP administration.
  • Experimental: Stage 2.1 (Allocetra-OTS in combination with anti-PD-1 therapy)
    Dose escalation of Allocetra-OTS up to 10 x 10\^9 cells by IV or IP administration, with IV nivolumab 240 mg.
  • Experimental: Stage 2.2 (Allocetra-OTS in combination with anti-PD-1 therapy)
    Dose escalation of Allocetra-OTS up to 10 x 10\^9 cells by IV or IP administration, with IV tislelizumab 200 mg.

Primary Outcome Measure

Safety of Allocetra-OTS [ Time Frame: 3-5 weeks ]

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