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

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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