Using Allocetra injections to treat Psoriatic Arthritis

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

This study is testing if Allocetra injections can safely help people with Psoriatic Arthritis who haven't found relief from other treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Enlivex Therapeutics Ltd. (Industry-sponsored)
• Locations: 4 sites (Haifa and 3 other locations)
• Trial ID: NCT06522035 on ClinicalTrials.gov

What this trial studies

This open-label study evaluates the safety and initial efficacy of Allocetra, an immunomodulatory cell-based therapy, administered via intra-articular injection in patients with Psoriatic Arthritis (PsA). The therapy involves modifying allogeneic peripheral blood mononuclear cells to reprogram macrophages, which play a key role in the disease's immunopathogenesis. The study will assess the safety of the injection in joints such as the knee, elbow, or ankle, and evaluate preliminary treatment responses in patients who have not adequately responded to standard therapies.

Who should consider this trial

Good fit: Ideal candidates include patients diagnosed with PsA who have at least one resistant or symptomatic joint despite standard treatment.

Not a fit: Patients who have had recent intra-articular injections or significant joint injuries may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with Psoriatic Arthritis who have not responded to existing treatments.

How similar studies have performed: While the approach of using macrophage-targeted therapies is emerging, this specific application of Allocetra is novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Haifa and 3 other locations

• Rambam Medical Center — Haifa, Israel (Recruiting)
• Carmel Medical Center — Haifa, Israel (Recruiting)
• Meir Medical Center — Kfar Saba, Israel (Recruiting)
• Tel Aviv Sourasky Medical Center - Ichilov — Tel Aviv, Israel (Recruiting)

Study contacts

• Study coordinator: Naama Kama

Conditions Arthritis, Psoriatic