Posoleucel for Multi-Virus Infection Prevention Post-Transplant
(Prevent Trial)

Recruiting in Palo Alto (17 mi)

+209 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: AlloVir

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing posoleucel, a treatment made from special immune cells, in high-risk patients who have had a stem cell transplant. The goal is to help their immune systems fight off six specific viruses and prevent infections.

Research Team

Eligibility Criteria

This trial is for patients who've had a stem cell transplant from a donor to treat blood or bone marrow conditions. They should be at least 1 year old, have received the transplant within the last 15-42 days, and not have active severe infections or graft-versus-host disease. Patients with recent serious viral diseases or high-dose steroid treatment are excluded.

Inclusion Criteria

You are at least 1 year old.\n

You received stem cells from a half-matched relative, a matched or unmatched unrelated donor, or umbilical cord blood.

Related (sibling) donor with at least one mismatch at one of these HLA-gene loci: HLA-A, -B or -DR

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Exclusion Criteria

History of AdV, BKV, CMV, EBV, HHV-6, and/or JCV end-organ disease within 6 months prior to randomization

Evidence of active Grade >2 acute GVHD

Presence of non-minor uncontrolled or progressive bacterial, viral or fungal infections

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Treatment Details

Interventions

Posoleucel (ALVR105,Viralym-M) (T cell Therapy)

Trial OverviewThe study tests Posoleucel (ALVR105), designed to prevent six different viral infections in patients after an allogeneic hematopoietic cell transplant. Participants will either receive this multi-virus specific T cell therapy or a placebo to compare effectiveness.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Posoleucel (ALVR105)Experimental Treatment1 Intervention

Administered as 2-4 milliliter infusion, visually identical to placebo

Group II: PlaceboPlacebo Group1 Intervention

Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)