ALPN-101 in Steroid-resistant or Steroid-refractory Acute GVHD

Stopped early · Phase 1

Conditions studied: Graft Vs Host Disease

In brief

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).

Key facts

Study ID

NCT04227938

Run by

Alpine Immune Sciences, Inc.

People needed

1

Starts

2020-05-11

Expected to finish

2020-05-21

Last updated by the study team

2023-08-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Female subjects must not be pregnant or breastfeeding.
• In addition, the following criteria must be met prior to dosing with ALPN-101 on Day 1:
• Karnofsky performance score ≥ 40.
• No evidence of an active, uncontrolled bacterial, viral, or fungal infection.

You may not qualify if…

• 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.
• 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.
• Known allergies, hypersensitivity, or intolerance to study drug, excipients, or similar compounds.
• Any medical complications or conditions that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.

Where it is running

• University of Miami — Miami, Florida, United States
• University of Kansas Hospital — Kansas City, Kansas, United States
• Sarah Cannon Center for Blood Cancer — Nashville, Tennessee, United States
• St. David's South Austin medical Center — Austin, Texas, United States

Full record on ClinicalTrials.gov

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