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RecruitingLast updated: 17 December 2025

R3ACT Fungal: Testing whether giving immune cells to people who have an invasive fungal infection after receiving a allogeneic stem cell transplantation helps to find the infectionA 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

Trial purpose

Medical clipboardSide effect and wellbeing

Tumor type

Blood Cancers Haematological

Age

People1 - 80

Trial acronym

R3ACT Fungal

Clinical summary

Summary

Fungal infections are 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. 

Researchers hope that these immune cells will shorten the amount of anti-fungal drugs requried and improve patient outcomes. 

Conditions

This trial is treating people with invasive fungal disease following allogeneic stem cell transplantation

Eligibility

Inclusion

- Recipients of myeloablative or non-myeloablative allogeneic stem cell transplantation from HLA-matched family or unrelated donor, mismatched family or unrelated donor or cord blood donor
- Proven or probable invasive fungal disease following transplant as defined by the internationally accepted criteria of the European Organisation for Research and Treatment of Cancer and the US-based Mycoses Study Group within 1 year of allogeneic stem cell transplant
- Patients has received no more than 28 days of a therapeutic dose of an anti-fungal drug prior to fungus-specific T-cell infusion (prophylactic anti-fungal agents not included). The choice of anti-fungal agents will be unrestricted and at the discretion of the treating physician
- Adequate hepatic and renal function (< 5 x upper limit of normal for AST (SGOT), ALT (SGPT), < 3 x upper limit of normal for total bilirubin, serum creatinine)
- ECOG status 0 to 3 or Lansky score 30-100
- Patient (or legal representative) has given informed consent.

Exclusion

- Use of anti-lymphocyte globulin (ALG, ATG, Campath or other broad spectrum lymphocyte antibody) in the 4 weeks immediately prior to fungus-specific T-cell infusion or planned within 4 weeks after infusion unless anti-lymphocyte globulin levels in blood shown to be below the lympholytic threshold prior to infusion.
- Active grade II or greater graft versus host disease within 1 week prior to infusion.
- Prednisone or methylprednisolone at a dose of > 1 mg/kg daily (or equivalent in other steroid preparations) administered within 72 hours prior to cell infusion.
- Dose of prednisone or methylprednisolone (if administered) not maintained at a stable level for 72 hours prior to T cell infusion
- Active and uncontrolled relapse of malignancy
- Severe peripheral cytopenia (ANC <0.5 x 10^9/L, platelet count <20 x 10^9/L unsupported)
- Active uncontrolled non-fungal infection including bacterial sepsis requiring commencement of systemic intravenous antibiotics in the 48 hours prior to T-cell infusion, active tissue infection with opportunistic viruses or untreated or progressing post-transplant lymphoproliferative disease
- Hypotension requiring fluid or pressor support, hypoxia or neurological features such as confusion or seizures in the 48 hours prior to T-cell infusion
- Patients requiring assisted respiration (eg: CPAP/intubation)
- ECOG status 4 or Lansky score <30
- Privately insured in or outpatients in New South Wales participating centres

Inclusion

  • You have had a certain type of treatment or surgical procedure.
  • You have the type of cancer, symptoms, or health risks that this clinical trial is focused on.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:

Trial sponsor

Western Sydney Local Health District

Scientific Title

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

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