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

Enlivex Therapeutics

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Solid Tumor; Peritoneal Cancer; Peritoneal Metastases

Treatments: Drug: Allocetra-OTS; Drug: Tislelizumab; Drug: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05581719

ENX-CL-04-002a

Details and patient eligibility

About

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.

Full description

Despite the advent of novel targeted and immunotherapeutics for the treatment of solid tumors, many patients remain without cure.

Allocetra-OTS is an immunomodulatory cell-based therapy consisting of allogeneic peripheral blood mononuclear cells that have been modified to be engulfed by macrophages and reprogram them into their homeostatic state.

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 (Stage 1), and in combination with an anti-PD-1 therapy (Stage 2).

Allocetra-OTS will be administered systemically or locally (intravenous [IV] or intraperitoneal [IP]) according to the tumor location.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients must have histologically or cytologically confirmed locally advanced, unresectable or metastatic solid tumors, that have relapsed or have been refractory to available approved therapies, or patients who are not eligible for or declined additional standard of care systemic therapy.

   Patients with peritoneal carcinomatosis can be eligible if an appropriate IP catheter or port can be placed.

2. Patients must have measurable disease.

3. Age ≥ 18 years old.

4. ECOG performance status ≤1.

5. Adequate renal function, hepatic function, and bone marrow function.

Exclusion criteria

1. Primary central nervous system (CNS) malignancy or CNS involvement, unless stable clinically.
2. Clinically significant uncontrolled infection, autoimmune or inflammatory diseases requiring systemic immunosuppression, clinically significant cardiovascular disease, severe pulmonary diseases or additional malignancies.
3. [For patients in Stage 2] Patients who previously experienced an ICI-related adverse reaction that resulted in discontinuation of the ICI.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

14 participants in 3 patient groups

Stage 1 (Allocetra-OTS monotherapy)

Experimental group

Description:

Dose escalation of Allocetra-OTS up to 10 x 10\^9 cells by IV or IP administration.

Treatment:

Drug: Allocetra-OTS

Stage 2.1 (Allocetra-OTS in combination with anti-PD-1 therapy)

Experimental group

Description:

Dose escalation of Allocetra-OTS up to 10 x 10\^9 cells by IV or IP administration, with IV nivolumab 240 mg.

Treatment:

Drug: Allocetra-OTS

Drug: Nivolumab

Stage 2.2 (Allocetra-OTS in combination with anti-PD-1 therapy)

Experimental group

Description:

Dose escalation of Allocetra-OTS up to 10 x 10\^9 cells by IV or IP administration, with IV tislelizumab 200 mg.

Treatment:

Drug: Tislelizumab

Drug: Allocetra-OTS