Virus Specific T-cell Therapy for Cytomegalovirus Infection

(ACES Trial)

Recruiting at 30 trial locations

Age: Any Age

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Pediatric Transplantation & Cellular Therapy Consortium

Must not be taking: Immunosuppressive antibodies, JAK inhibitors

Disqualifiers: Uncontrolled infections, Active malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

52 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Michael Pulsipher, MD

Principal Investigator

Children's Hospital Los Angeles

Michael Keller, MD

Principal Investigator

Children's National Research Institute

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive partially-HLA matched allogeneic multivirus-specific VSTs to evaluate safety and antiviral activity

4 weeks

1 visit (in-person) for VST infusion

Follow-up

Participants are monitored for safety and effectiveness after VST infusion, including viral load and immune response assessments

3 months

Regular monitoring visits

Long-term follow-up

Overall survival and persistence of infused VSTs are monitored

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Virus Specific T-cell (VST)

Trial Overview 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.

How Is the Trial Designed?

Group I: Virus specific T cell lines (VSTs) against three viruses Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Pediatric Transplantation & Cellular Therapy Consortium

Lead Sponsor

Michael Pulsipher, MD

Lead Sponsor

Trials

5

Recruited

240+