TerminatedPhase 3

Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation

Stopped: Study discontinued as DSMB determined it was futile. No safety concerns were noted.

United States57 participantsStarted 2022-04-26

Plain-language summary

This study will assess the safety and efficacy of Posoleucel for the treatment of adenovirus (AdV) infection in pediatric and adult allo-HCT recipients receiving standard of care (SoC).

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. AdV viremia DNA ≥10,000 copies/mL, OR
✓. AdV viremia DNA results of ≥1,000 copies/mL, AND
✓. has absolute lymphocyte count \<180/mm3, OR
✓. has received T cell depletion OR
✓. had a cord blood transplant.

What they're measuring

Number of Participants With Undetectable Adenovirus Infection

Timeframe: Day 29 through Day 43 (Day 29 + 14 days; up to 43 days post-first infusion)

Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)

Timeframe: Up to 34 weeks

Trial details

NCT IDNCT05179057

SponsorAlloVir

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-01-31

Results submitted2024-04-15

View on ClinicalTrials.gov More Adenovirus Infection trials