Evaluation of Allocetra by Intra-articular Injection for the Treatment of Psoriatic Arthritis

NCT ID: NCT06522035

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2026-09-30

Brief Summary

This is an open label study to evaluate the safety and initial efficacy of intra-articular administration of Allocetra in patients with Psoriatic Arthritis (PsA).

Detailed Description

Psoriatic Arthritis (PsA) is a prevalent chronic inflammatory disease that mainly affects the synovial joints, and leads to inflammatory arthritis, in addition to skin manifestations. If left untreated, inflammatory arthritis leads to joint damage and deformities.

Allocetra 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.

As macrophages play a crucial role in the initiation of PsA immunopathogenesis, they are considered an emerging target for PsA treatment.

This study will assess the safety of Allocetra injection to the joint (knee, elbow or ankle) in patients with PsA, and evaluate the preliminary responses to treatment.

Conditions

Arthritis, Psoriatic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stage 1

Stage 1 will include patients who have been treated with standard PsA therapies, and are insufficiently responsive to treatment in one or more involved joints.

Group Type: EXPERIMENTAL

Allocetra

Intervention Type: DRUG

Intra-articular injecton of Allocetra into the target joint.

Stage 2

Stage 2 will include patients with oligoarticular PsA (1-4 joints involved), who have received at least one injection of corticosteroids to the target joint with insufficient response.

Group Type: EXPERIMENTAL

Allocetra

Intervention Type: DRUG

Intra-articular injecton of Allocetra into the target joint.

Interventions

Allocetra

Intra-articular injecton of Allocetra into the target joint.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Diagnosed with PsA.

2. Stage 1 patients:

At least one joint resistant to standard PsA treatments and on a stable dose of approved PsA treatment for at least 3 months prior to treatment.

3. Stage 2 patients:

At least one symptomatic joint following attempt of intra-articular injection of corticosteroids, with insufficient response.

4. Acceptable blood tests- Complete Blood Count (CBC), electrolytes, adequate renal function, adequate liver function.

Exclusion Criteria

1. Prior intra-articular injection to the target joint of steroids, hyaluronate or other drugs within 3 months prior to treatment.

2. Any significant injury to the target joint within the 6 months prior to treatment, or any surgery to the target joint within the 12 months prior to treatment.

3. Findings of acute fractures, severe loss of bone density, chondrocalcinosis and/or severe bone or joint deformity in the target joint.

4. Evidence of active local infection in the target joint.

5. Concomitant rheumatic, inflammatory or autoimmune disease other than PsA.

6. Other limb pain of unknown etiology.

7. Any evidence of clinically significant active infection.

8. Major medical condition as detailed in the protocol.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Enlivex Therapeutics Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rambam Medical Center

Haifa, , Israel

Site Status: RECRUITING

Carmel Medical Center

Haifa, , Israel

Site Status: RECRUITING

Meir Medical Center

Kfar Saba, , Israel

Site Status: RECRUITING

Tel Aviv Sourasky Medical Center - Ichilov

Tel Aviv, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Naama Kama

Role: CONTACT

naama@enlivexpharm.com

+972-52-3466908

Lital Weinfeld Bergman

Role: CONTACT

lital@enlivexpharm.com

+972-52-5527554

Facility Contacts

Yolanda Braun, Prof., MD

Role: primary

y_braun@rambam.health.gov.il

+972-502061905

Devy Zisman, Prof., MD

Role: primary

devyzi@clalit.org.il

+972-506265526

Shaye Kivity, Prof., MD

Role: primary

shaye.kivity@clalit.org.il

+972-52-666-8134

Ori Elkayam, Prof., MD

Role: primary

orie@tlvmc.gov.il

+972-524266893

Other Identifiers

ENX-CL-06-001

Identifier Type: -

Identifier Source: org_study_id