Antiviral Cellular Therapy for Enhancing T-cell Reconstitution Before or After Hematopoietic Stem Cell Transplantation
(ACES Trial)

Recruiting in Palo Alto (17 mi)

+29 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Michael Pulsipher, MD

No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of this study is to evaluate whether virus-specific T cell lines (VSTs) are safe and can effectively control three viruses (EBV, CMV, and adenovirus) in patients who have had a stem cell transplant and also in patients that have a primary immunodeficiency disorder with no prior stem cell transplant.

Eligibility Criteria

This trial is for patients who've had a stem cell transplant or have primary immunodeficiency with persistent or relapsed CMV, EBV, or adenovirus infections despite standard treatment. Eligible participants must be able to reduce steroid use and not be pregnant if applicable. Those with uncontrolled cancer, recent monoclonal antibody therapy, other cellular therapies, or uncontrolled infections are excluded.

Inclusion Criteria

Treatment of the following persistent or relapsed infections despite standard therapy:

- CMV: Treatment of persistent or relapsed CMV disease or infection after standard therapy. For CMV infection, standard therapy is defined as antiviral therapy with ganciclovir, foscarnet or cidofovir for at least 14 days.

- Adenovirus: Treatment of persistent or relapsed adenovirus infection or disease despite standard therapy. Standard therapy is defined as antiviral therapy with cidofovir or brincidofovir.

+10 more

Exclusion Criteria

Patients with active and uncontrolled relapse of malignancy (if applicable).

Patients receiving ATG, Campath, Basiliximab or other immunosuppressive monoclonal antibodies targeting T-cells within 28 days of screening for enrollment.

Patients who have received donor lymphocyte infusion (DLI) or other experimental cellular therapies within 28 days.

+2 more

Participant Groups

The study tests the safety and effectiveness of virus-specific T-cell (VST) infusions in controlling EBV, CMV, and adenovirus infections in individuals post-stem cell transplant or those with primary immunodeficiency disorders who haven't responded well to standard treatments.

1Treatment groups

Experimental Treatment

Group I: Virus specific T cell lines (VSTs) against three virusesExperimental Treatment1 Intervention

The study will evaluate whether partially-HLA matched allogeneic multivirus-specific VSTs, activated using overlapping peptide libraries spanning immunogenic antigens from CMV, adenovirus and EBV, will be safe and produce anti-viral effects in immunodeficient recipients infected with one of more of the targeted viruses that are persistent despite conventional anti-viral therapy.