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NCT03691376 · ClinicalTrials.gov registry record · Phase 1
Genetically Engineered Cells (NY-ESO-1 TCR Engineered T Cells and HSCs) After Melphalan Conditioning Regimen in Treating Patients With Recurrent or Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
A Phase 1 study, sponsored by Roswell Park Cancer Institute.
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT03691376: Clinical Trial Phase 1 study, sponsored by Roswell Park Cancer Institute.
NCT03691376 is a Phase 1 study that was terminated before completion, run by Roswell Park Cancer Institute. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03691376, a Phase 1 study, was terminated before completion, sponsored by Roswell Park Cancer Institute.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
This phase I trial studies the best dose and side effects of NY-ESO-1 T cell receptor (TCR) engineered T cells and how well they work with NY-ESO-1 TCR engineered hematopoietic stem cells (HSCs) after melphalan conditioning regimen in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back (recurrent) or does not respond to treatment (refractory). The melphalan conditioning chemotherapy makes room in the patient's bone marrow for new blood cells and blood-forming cells (stem cells) to grow. Giving NY-ESO-1 TCR T cells and stem cells after the conditioning chemotherapy is intended to replace the immune system with new immune cells that have been redirected to attack and kill the cancer cells and thereby improve immune system function against cancer. Giving NY-ESO-1 TCR engineered T cells and HSCs after melphalan may work better in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.
Primary Outcome
The frequency of toxicities will be tabulated by grade across all dose levels and cycles.
Interventions
- DRUG Melphalan
- BIOLOGICAL Aldesleukin
- OTHER Cellular Therapy
- BIOLOGICAL Autologous NY-ESO-1-specific CD8-positive T Lymphocytes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2019-03-08 |
| Est. Completion | 2024-06-24 |
| Phase | Phase 1 |
Why NCT03691376 stopped before completion
NCT03691376 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 4 interventions - of which Melphalan is the first listed.
NCT03691376 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03691376 about?
NCT03691376 is a clinical study titled "Genetically Engineered Cells (NY-ESO-1 TCR Engineered T Cells and HSCs) After Melphalan Conditioning Regimen in Treating Patients With Recurrent or Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer". This phase I trial studies the best dose and side effects of NY-ESO-1 T cell receptor (TCR) engineered T cells and how well they work with NY-ESO-1 TCR engineered hematopoietic stem cells (HSCs) after melphalan conditioning regimen in treating patients with ovarian, fallopian tube, or primary perito...
What is the current status of trial NCT03691376?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2019-03-08. Estimated completion is 2024-06-24.
What interventions are being tested in trial NCT03691376?
The interventions under investigation include: Melphalan (DRUG), Aldesleukin (BIOLOGICAL), Cellular Therapy (OTHER), Autologous NY-ESO-1-specific CD8-positive T Lymphocytes (BIOLOGICAL).
Who is sponsoring clinical trial NCT03691376?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03691376's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 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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