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NCT04596033 · ClinicalTrials.gov registry record · Phase 1
TiTAN-1: Safety, Proliferation and Persistence of GEN-011 Autologous Cell Therapy
A Phase 1 study, sponsored by Genocea Biosciences.
- Terminated
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
NCT04596033: Clinical Trial Phase 1 study, sponsored by Genocea Biosciences.
NCT04596033 is a Phase 1 study that was terminated before completion, run by Genocea Biosciences. The registered enrollment target is 49 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04596033, a Phase 1 study, was terminated before completion, sponsored by Genocea Biosciences.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
Study Summary
TiTAN-1 is a first-in-human study of GEN-011, an experimental treatment being evaluated in adult patients with advanced cancer. GEN-011 is a T cell therapy made specific to each patient, using the patient's own circulating immune cells. First, Genocea confirms which cancer proteins are recognized already by each patient's T cells using ATLAS™. Then, immune cells that recognize these cancer proteins are multiplied many times (a process called PLANET™) to create a personalized GEN-011 cell therapy, which is given back to the patient in one or more intravenous (IV) infusions.
Primary Outcome
Adverse events will be graded according to the NC Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG IL-2
- BIOLOGICAL GEN-011
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2020-11-11 |
| Est. Completion | 2022-06-27 |
| Phase | Phase 1 |
Why NCT04596033 stopped before completion
NCT04596033 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower).
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT04596033 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04596033 about?
NCT04596033 is a clinical study titled "TiTAN-1: Safety, Proliferation and Persistence of GEN-011 Autologous Cell Therapy". TiTAN-1 is a first-in-human study of GEN-011, an experimental treatment being evaluated in adult patients with advanced cancer. GEN-011 is a T cell therapy made specific to each patient, using the patient's own circulating immune cells. First, Genocea confirms which cancer proteins are recognized al...
What is the current status of trial NCT04596033?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2020-11-11. Estimated completion is 2022-06-27.
What interventions are being tested in trial NCT04596033?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), IL-2 (DRUG), GEN-011 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04596033?
This trial is sponsored by Genocea Biosciences, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04596033's enrollment target sits among peer trials
49 1017th of 2000 higher than 976 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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