RecruitingPhase 1ACTRN12620000141943

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

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

Sponsor

QIMR Berghofer Medical Research Institute

Enrollment

20 participants

Start Date

Jun 19, 2020

Study Type

Interventional

Conditions

Haplo-identical haematopoietic stem cell transplantation

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 (called T cells) are removed from the transplant before it is given. In this trial, we will test a new preventative T cell therapy for four common viruses in patients 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.

Eligibility

Sex: Both males and femalesMin Age: 3 MonthssMax Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Children who receive a stem cell transplant from a partially matched (haploidentical) donor are at high risk of serious viral infections because the transplant process requires removing immune cells — including the T cells that normally fight viruses — before the transplant is given. This leaves children vulnerable, sometimes fatally so, in the weeks and months after transplant. This Phase 1 trial tests a new preventative therapy: virus-fighting T cells grown in the laboratory from the transplant donor's blood, then given to the child after transplant. The therapy targets four common viruses that frequently cause serious illness in these children. The primary goal is to confirm that this approach is safe and that the donated T cells can help rebuild the child's immune defences. You may be eligible if your child is aged 3 months to 18 years, requires a haploidentical stem cell transplant, and has a willing and eligible donor aged 18 or over who can provide blood for the therapy. Participation in the treatment phase requires additional criteria to be met at the time of the planned infusions.

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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). In this trial, IP will be generated for each participant from the peripheral blood of the haploidentical haematopoietic stem cell transplant (haplo-HSCT) donor. The safety of the IP in a preventative (prophylactic) setting will be tested in 20 paediatric TCRaß+/CD19+-depleted haplo-HSCT recipients. Participants will be recruited from Queensland Children’s Hospital, The Royal Children’s Hospital Melbourne, The Children’s Hospital at Westmead, and Sydney Children’s Hospital. Patients and donors will be recruited prior to donor stem cell mobilisation, and the IP will be generated from the peripheral blood of the donor, with manufacturing conducted at Q-Gen Cell Therapeutics. IP infusions will commence following engraftment, once the criteria for infusion commencement are met, and each infusion will be given at the recruiting hospital. Participants will receive up to six fortnightly intravenous infusions (depending on the number of cells grown), at a dose of twenty million cells per metre squared of body surface area, suspended in 20 mL clinical grade normal saline. 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(1)

NSW,QLD,VIC, Australia

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ACTRN12620000141943