RecruitingPhase 1ACTRN12621000323820

Virus-specific T cell therapy for transplant recipients

Phase I open-label clinical trial of allogeneic multi-virus-specific T cells for the treatment of viral complications in transplant recipients

Sponsor

QIMR Berghofer Medical Research Institute

Enrollment

25 participants

Start Date

May 31, 2021

Study Type

Interventional

Conditions

recurrent or drug-resistant viral infection Viral reactivation BK polyomavirus Disease relating to cytomegalovirus

Summary

Infectious complications following solid organ transplantation remains a major concern for transplant recipients. It is now firmly established that a delay in mounting virus-specific immune responses following transplant is a critical factor in allowing virus reactivation and viral disease. In particular, a group of immune cells called ‘T cells’ is important in fighting viruses. In this project we are focussing on four common viruses that cause complications in transplant patients: Epstein–Barr virus, cytomegalovirus, BK polyomavirus and adenovirus. In this trial we will test a therapeutic T cell therapy for solid organ transplant patients who are experiencing virus reactivation or disease. The T cell therapy has been grown from healthy donors and is ready to be administered to the transplant patients. Patients will receive four intravenous infusions of T cells over a period of approximately 4 weeks, and will then be followed up for approximately 14 weeks. 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 proportion of virus-specific immune T cells increases from before the first treatment, to the end of treatment and the end of follow-up.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

After receiving a solid organ transplant (such as a kidney, lung, heart, or liver), patients take powerful medications to prevent rejection, but these same medications suppress the immune system, making them vulnerable to viral infections. Viruses like cytomegalovirus (CMV), Epstein–Barr virus (EBV), BK virus (BKV), and adenovirus can cause serious complications — and sometimes standard antiviral treatments don't work. This trial is testing a specialised T cell therapy: immune cells grown from healthy donors that are specifically trained to fight these four viruses. The treatment involves four intravenous infusions of donor T cells given over about four weeks. Participants are then monitored for approximately 14 weeks afterwards to assess safety and to measure whether the proportion of virus-fighting immune cells increases. To be eligible, you must be 18 or older, have previously received a solid organ transplant, and have an active viral infection (CMV, EBV, BKV, or adenovirus) that has not responded to standard treatments or where standard treatments cannot be used. This trial represents an exciting frontier in treating transplant complications using the body's own immune system — just sourced from a compatible healthy donor.

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

The investigational product (IP) is ‘multi-virus-specific T cells TI1’, and consists of T cells targeting cytomegalovirus (CMV), Epstein–Barr virus (EBV), BK polyomavirus (BKV) and adenovirus (AdV). IP has previously been be generated in a good manufacturing practices (GMP) facility from the peripheral blood of healthy donors recruited via the Australian Bone Marrow Donor Registry. Batches of IP will be selected for participants based on human leukocyte antigen matching and virus specificity of the product. The safety of the IP in a therapeutic setting will be tested in 25 patients who have received a solid organ transplant (kidney, lung, heart, liver, or a combination of these). Participants will be recruited from Princess Alexandra Hospital, The Prince Charles Hospital, Royal Brisbane and Women’s Hospital and Royal Adelaide Hospital. Administration of the Investigational product will be reordered in the case report forms and records of use in the product accountability logs. Four intravenous infusions of 4 × 10e7 cells suspended in clinical grade saline per infusion will be given; the second infusion will be 2 weeks after infusion one, to allow time to detect any immediate safety issues, and then infusions three and four will be delivered at 1-week intervals. At the Clinical Investigator’s discretion, the batch of T cells may be changed after two infusions. The IP will be administered intravenously over 5–10 min by a qualified person (e.g. registered nurse or clinician). This will be followed by a saline flush, which will take an additional 5–10 min.

Locations(4)

The Prince Charles Hospital - Chermside

QLD,SA, Australia

Princess Alexandra Hospital - Woolloongabba

QLD,SA, Australia

The Royal Adelaide Hospital - Adelaide

QLD,SA, Australia

Royal Brisbane & Womens Hospital - Herston

QLD,SA, Australia

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ACTRN12621000323820