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NCT03449108 · ClinicalTrials.gov registry record · Phase 2
LN-145 or LN-145-S1 in Treating Patients With Relapsed or Refractory Ovarian Cancer, Triple Negative Breast Cancer (TNBC), Anaplastic Thyroid Cancer, Osteosarcoma, or Other Bone and Soft Tissue Sarcomas
A Phase 2 study of Malignant Solid Neoplasm and Recurrent Ovarian Carcinoma, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT03449108: Active Phase 2 study of Malignant Solid Neoplasm and Recurrent Ovarian Carcinoma, sponsored by M.D. Anderson Cancer Center.
NCT03449108 is a Phase 2 study of Malignant Solid Neoplasm and Recurrent Ovarian Carcinoma that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 30 participants, below the 1,141-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03449108, a Phase 2 study of Malignant Solid Neoplasm and Recurrent Ovarian Carcinoma, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well autologous tumor infiltrating lymphocytes LN-145 (LN-145) or LN-145-S1 works in treating patients with ovarian cancer, triple negative breast cancer (TNBC), anaplastic thyroid cancer, osteosarcoma, or other bone and soft tissue sarcomas that do not respond to treatment (refractory) or that has come back (relapsed). LN-145 is made by collecting and growing specialized white blood cells (called T-cells) that are collected from the patient's tumor. LN-145-S1 is made using a modified process that chooses a specific portion of the T-cells. The T cells may specifically recognize, target, and kill the tumor cells.
Primary Outcome
Assessed by Response Evaluation Criteria in Solid Tumors version 1.1. Estimation will use 80% confidence intervals by the Wilson score method.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- BIOLOGICAL Aldesleukin
- BIOLOGICAL Autologous Tumor Infiltrating Lymphocytes LN-145
- BIOLOGICAL Autologous Tumor Infiltrating Lymphocytes LN-145-S1
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2018-04-27 |
| Est. Completion | 2027-04-30 |
| Phase | Phase 2 |
What the registry record for NCT03449108 still lists
NCT03449108 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,141-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (97% lower).
The record links to 10 conditions, with Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT03449108 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03449108 about?
NCT03449108 is a clinical study titled "LN-145 or LN-145-S1 in Treating Patients With Relapsed or Refractory Ovarian Cancer, Triple Negative Breast Cancer (TNBC), Anaplastic Thyroid Cancer, Osteosarcoma, or Other Bone and Soft Tissue Sarcomas". This phase II trial studies how well autologous tumor infiltrating lymphocytes LN-145 (LN-145) or LN-145-S1 works in treating patients with ovarian cancer, triple negative breast cancer (TNBC), anaplastic thyroid cancer, osteosarcoma, or other bone and soft tissue sarcomas that do not respond to tre...
What is the current status of trial NCT03449108?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2018-04-27. Estimated completion is 2027-04-30.
What conditions does trial NCT03449108 study?
This clinical trial studies the following conditions: Malignant Solid Neoplasm, Recurrent Ovarian Carcinoma, Platinum-Resistant Ovarian Carcinoma, Recurrent Osteosarcoma, Bone Sarcoma.
What interventions are being tested in trial NCT03449108?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Aldesleukin (BIOLOGICAL), Autologous Tumor Infiltrating Lymphocytes LN-145 (BIOLOGICAL), Autologous Tumor Infiltrating Lymphocytes LN-145-S1 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03449108?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03449108 being conducted?
This trial has 1 study location across Texas. 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 NCT03449108's enrollment target sits among peer trials
30 146th of 176 higher than 26 of 176 other Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Solid Neoplasm 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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