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NCT01875653 · ClinicalTrials.gov registry record · Phase 3
Autologous Dendritic Cell-Tumor Cell Immunotherapy for Metastatic Melanoma
A Phase 3 study, sponsored by Lisata Therapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 4
- Enrollment target
NCT01875653: Clinical Trial Phase 3 study, sponsored by Lisata Therapeutics.
NCT01875653 is a Phase 3 study that was terminated before completion, run by Lisata Therapeutics. The registered enrollment target is 4 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01875653, a Phase 3 study, was terminated before completion, sponsored by Lisata Therapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 4 participants
- Enrollment target
Study Summary
The purpose of this research is to evaluate the safety and effectiveness of tumor cell therapy. This research study is evaluating if a patient-specific experimental therapy for metastatic melanoma will lengthen survival with minimal harmful effects. It is called an experimental therapy (or "study therapy") because it is not yet approved by the U.S. Food and Drug Administration (FDA). This research study will use the patient's own tumor cells,the patient's own dendritic cells (a type of immune cell), and a granulocyte-macrophage colony stimulating factor (GM-CSF, a type of growth factor). GM-CSF is a natural growth factor that stimulates growth of white blood cells in the body. Since 1991, GM-CSF has been used as a standard treatment to help increase the number of white blood cells after chemotherapy. The patient's dendritic cells are grown in a test-tube with the patient's tumor cells and the growth factor. The resulting solution is called the study therapy. The intent of the study therapy is to make the dendritic cells more effective at fighting the tumor when they are injected back into the patient.
Primary Outcome
The time frames are estimated time in months (rounded up to the nearest month) from the start of study. The time estimates for the analyses are based on enrolling approximately 250 patients over a 34.8 months period and having a follow up of approximately 17 months after the last patient is enrolled.
Interventions
- BIOLOGICAL Autologous Dendritic Cell-Tumor Cell Immunotherapy (DC-TC)
- BIOLOGICAL Autologous PBMCs in GM-CSF (MC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2014-10 |
| Est. Completion | 2016-01 |
| Phase | Phase 3 |
Why NCT01875653 stopped before completion
NCT01875653 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Autologous Dendritic Cell-Tumor Cell Immunotherapy (DC-TC) is the first listed.
NCT01875653 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01875653 about?
NCT01875653 is a clinical study titled "Autologous Dendritic Cell-Tumor Cell Immunotherapy for Metastatic Melanoma". The purpose of this research is to evaluate the safety and effectiveness of tumor cell therapy. This research study is evaluating if a patient-specific experimental therapy for metastatic melanoma will lengthen survival with minimal harmful effects. It is called an experimental therapy (or "study t...
What is the current status of trial NCT01875653?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 4 participants. The study started on 2014-10. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01875653?
The interventions under investigation include: Autologous Dendritic Cell-Tumor Cell Immunotherapy (DC-TC) (BIOLOGICAL), Autologous PBMCs in GM-CSF (MC) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01875653?
This trial is sponsored by Lisata Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01875653's enrollment target sits among peer trials
4 1998th of 2000 higher than 2 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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