Phase I trial of multi-virus-specific T cells for paediatric haploidentical -stem cell transplant recipients

Phase 1

Recruiting

• Conditions: Haplo-identical haematopoietic stem cell transplantation; Blood - Haematological diseases; Infection - Other infectious diseases

• Registration Number: ACTRN12620000141943
• Lead Sponsor: QIMR Berghofer Medical Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-12
• Last Update Posted: 10 October 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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 Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of adverse events, and clinically significant changes in laboratory tests and vital signs observations.[Adverse events will be collected at each visit, commencing at the first infusion visit, and finishing approximately 10 weeks following the final infusion. Safety blood tests (FBC, ELFT, and viral load) will be collected at the first infusion visit until the final follow-up visit, approximately 7.5 months following the final infusion. Vital signs observations will be done during and immediately following each T cell infusion. ]

Secondary Outcome Measures

Name	Time	Method
The change in the proportion of functional virus-specific T cells, from prior to the first infusion to the first follow-up visit and at final follow-up. [Blood will be collected at each study visit (all infusions and follow-up visits) to allow the examination of peripheral blood mononuclear cells. These cells will be analysed to assess their phenotype and function over the course of the trial to determine any changes. ]