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NCT05993299 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate Safety and Antitumor Activity of Lete-Cel (GSK3377794) in HLA-A2+ Participants With NY-ESO-1 Positive Previously Untreated Advanced (Metastatic or Unresectable) Synovial Sarcoma and Myxoid/Round Cell Liposarcoma
A Phase 2 study of Neoplasms, sponsored by USWM, LLC (dba US WorldMeds).
- Active
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
- 20
- Study locations
NCT05993299: Active Phase 2 study of Neoplasms, sponsored by USWM, LLC (dba US WorldMeds).
NCT05993299 is a Phase 2 study of Neoplasms that is active but no longer recruiting, run by USWM, LLC (dba US WorldMeds). The registered enrollment target is 7 participants, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (100% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05993299, a Phase 2 study of Neoplasms, is active but no longer recruiting, sponsored by USWM, LLC (dba US WorldMeds).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
- 20
- Study locations
Study Summary
This trial will evaluate safety and efficacy of human engineered T-cell therapies, in participants with advanced tumors. This trial is a sub study of the Master study NCT03967223.
Primary Outcome
ORR is defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) via investigator assessment per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) version 1.1 relative to the total number of participants in the analysis population. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm). PR is defi
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Letetresgene autoleucel
Study Locations (20)
California
- City of Hope National Medical Center - Duarte
- Stanford Hospital and Clinics - Stanford
Massachusetts
- Dana Farber Cancer Institute - Boston
- Massachusetts General Hospital - Boston
Minnesota
- Minnesota Oncology Hematology - Minneapolis
- Mayo Clinic Rochester - Rochester
Texas
- University Of Texas Southwestern Medical Center - Dallas
- University of Texas Southwestern Medical Center - Dallas
Colorado
- Sarah Cannon Research Institute - Denver
Florida
- Mayo Clinic Jacksonville - Jacksonville
Illinois
- University of Chicago - Chicago
Iowa
- University of Iowa College of Medicine - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2019-12-31 |
| Est. Completion | 2026-07-01 |
| Phase | Phase 2 |
What the registry record for NCT05993299 still lists
NCT05993299 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Neoplasms appearing as the primary indexed condition, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT05993299 names 20 study sites across 16 states, led by California, Massachusetts, Minnesota.
Frequently Asked Questions
What is clinical trial NCT05993299 about?
NCT05993299 is a clinical study titled "Study to Evaluate Safety and Antitumor Activity of Lete-Cel (GSK3377794) in HLA-A2+ Participants With NY-ESO-1 Positive Previously Untreated Advanced (Metastatic or Unresectable) Synovial Sarcoma and Myxoid/Round Cell Liposarcoma". This trial will evaluate safety and efficacy of human engineered T-cell therapies, in participants with advanced tumors. This trial is a sub study of the Master study NCT03967223.
What is the current status of trial NCT05993299?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2019-12-31. Estimated completion is 2026-07-01.
What conditions does trial NCT05993299 study?
This clinical trial studies the following conditions: Neoplasms.
What interventions are being tested in trial NCT05993299?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Letetresgene autoleucel (DRUG).
Who is sponsoring clinical trial NCT05993299?
This trial is sponsored by USWM, LLC (dba US WorldMeds), which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05993299 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05993299's enrollment target sits among peer trials
7 158th of 158 higher than 1 of 158 other Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms 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.
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