RecruitingPhase 1ACTRN12618001540202

Fungus-specific immune cells for bone marrow transplant patients with invasive fungal disease

A phase 1 trial of HLA-DR matched third party donor-derived fungus-specific cytotoxic T-lymphocytes in patients with invasive fungal disease post-allogeneic stem cell transplantation

Sponsor

Western Sydney Local Health District

Enrollment

20 participants

Start Date

Feb 5, 2021

Study Type

Interventional

Conditions

Invasive Fungal Disease

Summary

Fungal infections after receiving a bone marrow transplant is lethal and requires costly anti-fungal treatment . This study will give immune cells to transplant patients to fight the infection. We hope that these immune cells will shorten the amount of anti-fungal drugs required and improve patient outcomes.

Eligibility

Sex: Both males and femalesMin Age: 1 YearsMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

Bone marrow transplantation (also called stem cell transplantation) is a life-saving treatment for some blood cancers and blood disorders. However, the process of transplantation suppresses the immune system, leaving patients very vulnerable to infections. Fungal infections in particular — caused by moulds and yeasts — can be life-threatening in this setting and are very difficult to treat with standard antifungal medications alone. This study tests a new approach: infusing immune cells (called T-cells) that have been specifically trained to recognise and attack fungal organisms. These fungus-specific T-cells are collected from the original stem cell donor and then manufactured and prepared in the laboratory. The hope is that these targeted immune cells will fight the fungal infection more effectively, shorten the time patients need antifungal drugs, and improve survival. To be eligible you need to have received an allogeneic (donor) stem cell transplant and then developed a proven or probable invasive fungal infection within one year of transplant. You must not have received more than 28 days of full-dose antifungal treatment before the T-cell infusion, and must have adequate liver and kidney function. People with active severe graft-versus-host disease, high-dose steroid use, or other serious active infections are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Phase 1 trial of three dose levels of third party, donor-derived fungus-specific cytotoxic T-lymphocytes (CTL's) in patients with invasive fungal disease post-allogeneic stem cell transplantation. Pa

Phase 1 trial of three dose levels of third party, donor-derived fungus-specific cytotoxic T-lymphocytes (CTL's) in patients with invasive fungal disease post-allogeneic stem cell transplantation. Patients will initially be given a dose of 1x10^6cells/m^2 followed by 1x10^7cells/m^2 and 1x10^8cells/m^2 no less than 14 days and no more than 3 months apart. The decision to proceed with the next infusion will be in the opinion of the treating physician and the Chief Investigator if it is in the patient’s best interest to do so. Factors such as toxicity from previous infusions, response of disease to previous infusion and concomitant medications will be considered. The infusion will be given via intravenous infusion over 5 minutes. The patient may receive the infusion as an outpatient (eg: Cancer Day Suite) but it is recommended that they remain in hospital for at least 7 days after the administration of T-cells for monitoring of potential complications of therapy. Given the patient disease it is likely they will already be an inpatient.