AzTrials
AzTrials

Graft Vs Host DiseasePhase 1BalanceNCT04227938

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

A Phase 1 study testing ALPN-101 in people with Graft Vs Host Disease, run by Alpine Immune Sciences, Inc. at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Graft Vs Host Disease
What is being tested?
ALPN-101
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
4 sitesUnited States
Study dates
11 May 2020to 21 May 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • St. David's South Austin medical Center

    Austin, Texas, 78704

  • University of Kansas Hospital

    Kansas City, Kansas, 66160

  • University of Miami

    Miami, Florida, 33136

  • Sarah Cannon Center for Blood Cancer

    Nashville, Tennessee, 37203

Other trials in United States

About this study

Official title: An Open-label Study of ALPN-101 in Steroid-resistant or Steroid-refractory Acute Graft Versus Host Disease (aGVHD)

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).

Read the detailed description

AIS-A02 is a Phase 1b open-label study of ALPN-101 administered to adult subjects with steroid-resistant or steroid-refractory acute graft versus host disease (aGVHD).

It will be conducted at approximately 10 US sites. Up to 72 subjects will be enrolled in Part A (dose escalation) and up to 25 subjects will be enrolled in Part B (dose expansion).

In each Part, safety and efficacy assessments will be performed throughout the dosing and follow-up periods, and multiple PK and PD samples will be collected.

Being tested
ALPN-101
Keywords
steroid-resistant acute graft versus host disease, steroid-refractory acute graft versus host disease
Medical subject headings
Graft vs Host Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ALPN-101Drug

    A single dose of ALPN-101 will be administered via intravenous infusion.

Study groups in NCT04227938
Study groupRoleWhat they receive
ALPN-101ExperimentalAll subjects will receive a single dose of ALPN-101. In Part A, ascending dose levels of ALPN-101 will be evaluated. In Part B, a single dose level of ALPN-101-as identified in Part A-will be evaluated.
Receives: Drug: ALPN-101

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events

    The incidence, severity, and seriousness of AEs, including dose-limiting toxicities, assessed by CTCAE

    Measured: From study Day 1 (dosing of ALPN-101) until Day 29

Secondary outcomes (10)

  1. Objective Response Rate (ORR)

    Assessed by MAGIC criteria

    Measured: From study Day 1 (dosing of ALPN-101) until the date of best response, assessed up to 36 months

  2. Duration of Response (DOR)

    Measured: From the date of best response until disease progression, assessed up to 36 months

  3. Failure-free survival (FFS)

    Measured: From study Day 1 (dosing of ALPN-101) until relapse, initiation of new systemic therapy, or non-relapse mortality; assessed up to 36 months

  4. Event-free survival (EFS)

    Measured: From study Day 1 (dosing of ALPN-101) until disease (aGVHD)-related event or death due to any cause, assessed up to 36 months

  5. Non-relapse mortality (NRM)

    Measured: From study Day 1 (dosing of ALPN-101) until progression or death due to any cause without prior progression, assessed up to 36 months

  6. Malignancy relapse/progression (MR)

    Measured: From study Day 1 (dosing of ALPN-101) until the date of relapse/progression of the primary malignancy, assessed up to 36 months

  7. Overall survival (OS)

    Measured: From study Day 1 (dosing of ALPN-101) until death due to any cause, assessed up to 36 months

  8. Time to maximum observed concentration (tmax) of ALPN-101

    Measured: From study Day 1 (dosing of ALPN-101) until Day 29

  9. Maximum observed concentration (Cmax) of ALPN-101

    Measured: From study Day 1 (dosing of ALPN-101) until Day 29

  10. Area under the concentration-time curve (AUC) of ALPN-101

    Measured: From study Day 1 (dosing of ALPN-101) until Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2020
  2. Study start11 May 2020
  3. Primary completion21 May 2020
  4. Study completion21 May 2020

Why it stopped: Change in sponsor strategy

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
A single dose of ALPN-101 will be administered via intravenous (IV) infusion. Multiple, ascending dose levels will be evaluated in cohorts of 3-6 subjects in Part A. In Part B, a single dose level-as identified in Part A-is planned.
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04227938
Sponsor's protocol ID
AIS-A02
Acronym
Balance
Status last verified
Aug 2020
First submitted
6 Jan 2020
Last updated
28 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ALPN-101 in people with Graft Vs Host Disease, run by Alpine Immune Sciences, Inc. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Change in sponsor strategy). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (time frame: From study Day 1 (dosing of ALPN-101) until Day 29). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04227938.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in