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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 is a Phase 1 study that was terminated before completion, run by Genocea Biosciences. The registered enrollment target is 49 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04596033
The ClinicalTrials.gov registry entry for NCT04596033 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genocea Biosciences, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT04596033 reports 0 study locations.
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.
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