T1DM Immunotherapy Using Polyclonal Tregs + IL-2
Model scores of the 29,894 trials active now.
Model score 18% for any early termination, 6% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 8% of the time (137 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2021-08-27, after 2016-08-31 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2021-08-27. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: chronicdiabetesdosingand effectivethe safety
Phrases that lowered it: patients whoaccordingtrial000safety of -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 1 (lowers risk) · Design
-
Responsible party: sponsor investigator (raises risk) · Design
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Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Number of arms: 1 (raises risk) · Design
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Maximum age: 45 (lowers risk) · Who can join
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Collaborators: 1 (raises risk) · Design
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 1 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 45 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic, immunology, endocrine
- Drugs matched to FDA substances
- none matched
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- T1DM Immunotherapy Using CD4+CD127lo/-CD25+ Polyclonal Tregs NCT01210664 · started 2010 · scored riskier than 69% of active trials completed
- Dose-effect Relationship of Low-dose IL-2 in Type 1 Diabetes NCT01353833 · started 2011 · scored riskier than 86% of active trials completed
- Dose Finding Study of Il-2 at Ultra-low Dose in Children With Recently Diagnosed Type 1 Diabetes NCT01862120 · started 2013 · scored riskier than 70% of active trials completed
- Safety and Efficacy of CLBS03 in Adolescents With Recent Onset Type 1 Diabetes (The Sanford Project T-Rex Study) NCT02691247 · started 2016 · scored riskier than 31% of active trials completed
- PolyTreg Immunotherapy in Islet Transplantation NCT03444064 · started 2018 · scored riskier than 56% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.