ALPN-101 in Steroid-resistant or Steroid-refractory Acute GVHD (NCT04227938) | Clinical Trial Compass
TerminatedPhase 1
ALPN-101 in Steroid-resistant or Steroid-refractory Acute GVHD
Stopped: Change in sponsor strategy
United States1 participantsStarted 2020-05-11
Plain-language summary
The Balance study will assess the safety, tolerability, and efficacy of an investigational drug called ALPN-101 in adults with steroid-resistant or steroid-refractory acute graft versus host disease (aGVHD).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years
✓. Status post first allogeneic stem cell transplantation (allo-SCT) from any donor source using any conditioning regimen.
✓. Grade Ⅱ-Ⅳ acute GVHD per Mount Sinai Acute GVHD international Consortium (MAGIC) criteria.
✓. Corticosteroid resistant or refractory as defined as any of the following:
✓. Progression of aGVHD within 5 days following initiation of treatment with ≥ 2 mg/kg/day of prednisone or equivalent;
✓. Failure to improve within 7 days following initiation of treatment with ≥ 2 mg/kg/day of prednisone or equivalent; or
✓. Incomplete response (failure to achieve Complete Response) after 28 days of immunosuppressive treatment including steroids (treatment with ≥ 2 mg/kg/day of prednisone or equivalent).
✓. Must agree to use appropriate contraception.
Exclusion criteria
✕. Current veno-occlusive disease, or current treatment with dialysis or mechanical ventilation associated with GVHD.
✕. Prior donor lymphocyte infusion (DLI).
✕. Receipt of any live vaccine within 4 weeks of ALPN-101 dosing.
✕. Presence of any active malignant disease.
What they're measuring
1
Adverse events
Timeframe: From study Day 1 (dosing of ALPN-101) until Day 29
. Corticosteroid therapy at doses \> 1 mg/kg/day prednisone or equivalent for indications other than GVHD ≤ 7 days p ALPN-101 dosing.
✕. Treatment with any of the following ≤ 2 weeks prior to ALPN-101 dosing: targeted inhibitors of the CD28/CD80/86 pathway (e.g. abatacept, belatacept), targeted inhibitors of the ICOS/ICOSL pathway
✕. Initiation of treatment with salvage therapy \< 2 days prior to ALPN-101 dosing. Concurrent salvage therapy that is intended to be continued must be at a stable dose for ≥ 2 days prior to ALPN-101 dosing.
✕. Treatment for aGVHD with adoptive cell therapy, investigational agents, devices, or procedures ≤ 2 weeks or 5 half-lives-whichever is greater-prior to ALPN-101 dosing, unless approved by the medical monitor and sponsor; prior treatment with mesenchymal stem cells is permitted.