Virus-specific T cell therapy for transplant recipients

Phase 1

Recruiting

• Conditions: Viral reactivation; recurrent or drug-resistant viral infection; Disease relating to cytomegalovirus; Epstein–Barr virus; BK polyomavirus; Adenovirus.; Infection - Other infectious diseases

• Registration Number: ACTRN12621000323820
• 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: 2021-03-23
• Last Update Posted: 13 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Aged 18 years or above
2. Previously received a solid organ transplant (kidney, lung, heart, liver, or a combination of these)
3. Viral infection or virus-induced neoplasia due to CMV, EBV, BKV or AdV, which is proven or suspected to be refractory to standard of care, or where standard of care is relatively or absolutely contraindicated.
4. Availability of a suitable batch of IP

Exclusion Criteria

1. Significant non-malignant disease, e.g. severe cardiac or respiratory dysfunction
2. Uncontrolled psychosis, substance dependence, or any other psychiatric condition that may compromise the ability to participate in this trial
3. Prior cancers except: cancers with no evidence of disease recurrence and clinical expectation of recurrence of <5%; successfully treated non-melanoma skin cancer; localised prostate cancer; or carcinoma in situ of the cervix; or virus-induced neoplasia as specified in inclusion criterion 3.
4. Women who are pregnant, lactating or unwilling to use adequate contraception
5. Any other medical condition that, in the view of the Clinical Investigator, would prohibit participation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of adverse events. Parameters collected include Abnormal laboratory findings and other abnormal assessments (eg vital signs observations etc) and participant-reported adverse events. [Adverse events will be collected at each visit commencing at the first infusion. Visit Infusions are weeks 2, 4, 5, 6, and follow-up visits approx. weeks 8, 12, 16, and 20.];Clinically significant changes in laboratory tests. Blood tests will be haematology, biochemistry, and lymphocyte subsets[Blood Results will be collected at each visit commencing the first infusion. Visit infusion are week 2, 4, 5, 6 and follow up visits approx. week 8, 12, 16 and 20 ];Clinically Significant Change in vital signs. This will include Blood pressure (via blood pressure cuff), heart rate and oxygen saturation (via a pulse oximeter), respiratory rate (by counting) and temperature (via a tympanic thermometer) [Vital signs will be measured weeks 2, 4, 5 and 6 ]

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 (Baseline is immediately prior to infusion 1. and 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. ]