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RecruitingLast updated: 24 February 2026

P3505: Testing whether giving specially prepared immune cells after a stem cell transplant can safely help children fight serious viral infections and recover betterPhase I clinical trial of the safety of adoptive transfer of multi-virus-specific T cells into TCRaß+/CD19+-depleted haploidentical HSCT recipients

Trial purpose

Medical clipboardSide effect and wellbeing

Tumor type

Blood Cancers Haematological

Age

People0 - 18

Trial acronym

P3505

Clinical summary

Summary

Patients who receive a type of transplant called a haploidentical haematopoietic stem cell transplant (haplo-HSCT), which is not an ideal tissue match for the patient, are at a high risk of developing a viral infection. This is because the immune cells that can fight viruses (caleld T-cells) are removed from the transplant before it is given.

In this trial, researchers will rest a new preventative T-cell therapy for four common viruses in people who have received a haplo-HSCT. The therapy will be grown from the blood of the transplant donor and given to patients after their transplant.

One aim of this trial is to see if this T-cell therapy is safe for transplant patients. In addition, we would like to see if the T-cells that we grow in the laboratory from the transplant donors can help to restore the recipients' immune systems. This may help prevent infectious complications from developing.

Conditions

This trial is treating people with a condition for which haematopoietic stem cell transplantation (HSCT) is indicated

Eligibility

Inclusion

1. Aged between 3 months and 18 years
2. Patient has a condition for which HSCT is indicated
3. Transplant physician determines that optimal donor is haploidentical*
4. Haplo-HSCT donor is aged 18 or above
5. Haplo-HSCT donor is available and willing to donate blood for therapy manufacture

* This decision is usually based upon lack of HLA matched sibling or fully matched unrelated donor, but may be influenced by other factors such as donor availability or urgency of HSCT.

Exclusion

The treatment protocol in part or in its entirety is declined by either the patient or their legal guardian.

NB: Additional criteria are in place for the commencement of infusions

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.

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Recruiting hospitals

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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

QIMR Berghofer Medical Research Institute

Scientific Title

Phase I clinical trial of the safety of adoptive transfer of multi-virus-specific T cells into TCRaß+/CD19+-depleted haploidentical HSCT recipients

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