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NCT01343043 · ClinicalTrials.gov registry record · Phase 1
A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1ᶜ²⁵⁹T in HLA-A2+ Patients With Synovial Sarcoma
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT01343043: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT01343043 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01343043, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
The purpose of this early (pilot) clinical trial is to test the effects (both good and bad) of chemotherapy and adoptive immunotherapy with T cells engineered to recognize NY-ESO-1 peptide in patients with unresectable, metastatic or recurrent synovial sarcoma.
Primary Outcome
ORR was calculated as the percentage of participants with a confirmed complete response (CR) or partial response (PR) relative to the total number of participants in the analysis population per response evaluation criteria in solid tumors (RECIST) version (v)1.1 as determined by the local investigators.
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG NY-ESO-1(c259)T Cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2012-09-27 |
| Est. Completion | 2019-06-18 |
| Phase | Phase 1 |
What the finished NCT01343043 record still lists
NCT01343043 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT01343043 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01343043 about?
NCT01343043 is a clinical study titled "A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1ᶜ²⁵⁹T in HLA-A2+ Patients With Synovial Sarcoma". The purpose of this early (pilot) clinical trial is to test the effects (both good and bad) of chemotherapy and adoptive immunotherapy with T cells engineered to recognize NY-ESO-1 peptide in patients with unresectable, metastatic or recurrent synovial sarcoma.
What is the current status of trial NCT01343043?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2012-09-27. Estimated completion is 2019-06-18.
What interventions are being tested in trial NCT01343043?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), NY-ESO-1(c259)T Cells (DRUG).
Who is sponsoring clinical trial NCT01343043?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01343043's enrollment target sits among peer trials
50 973rd of 2000 higher than 984 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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