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NCT05194735 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Study of Autologous T Cells to Express T-Cell Receptors (TCRs) in Subjects With Solid Tumors
A Phase 1 study, sponsored by Alaunos Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT05194735: Clinical Trial Phase 1 study, sponsored by Alaunos Therapeutics.
NCT05194735 is a Phase 1 study that was terminated before completion, run by Alaunos Therapeutics. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05194735, a Phase 1 study, was terminated before completion, sponsored by Alaunos Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
A Phase I/II study of autologous T cells engineered using the Sleeping Beauty transposon/transposase system to express TCR(s) reactive against neoantigens in subjects with relapsed/refractory solid tumors
Primary Outcome
Treatment-emergent adverse events (TEAEs) were defined as any adverse event that began or worsened after initiation of lymphodepletion and up to 28 days following TCR-T cell infusion. TEAEs were coded using MedDRA and summarized by system organ class and preferred term, severity, and relationship to study treatment. Participants were followed for delayed or ongoing toxicities for up to 1 year.
Interventions
- BIOLOGICAL Aldesleukin (IL-2)
- BIOLOGICAL Neoantigen specific TCR-T cell drug product
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2022-04-04 |
| Est. Completion | 2023-08-14 |
| Phase | Phase 1 |
Why NCT05194735 stopped before completion
NCT05194735 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Aldesleukin (IL-2) is the first listed.
NCT05194735 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05194735 about?
NCT05194735 is a clinical study titled "Phase I/II Study of Autologous T Cells to Express T-Cell Receptors (TCRs) in Subjects With Solid Tumors". A Phase I/II study of autologous T cells engineered using the Sleeping Beauty transposon/transposase system to express TCR(s) reactive against neoantigens in subjects with relapsed/refractory solid tumors
What is the current status of trial NCT05194735?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2022-04-04. Estimated completion is 2023-08-14.
What interventions are being tested in trial NCT05194735?
The interventions under investigation include: Aldesleukin (IL-2) (BIOLOGICAL), Neoantigen specific TCR-T cell drug product (BIOLOGICAL).
Who is sponsoring clinical trial NCT05194735?
This trial is sponsored by Alaunos Therapeutics, which has 22 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05194735's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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