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NCT06043713 · ClinicalTrials.gov registry record · Phase 1
Autologous CD8+ and CD4+ Transgenic T Cells Expressing High Affinity KRASG12V Mutation-Specific T Cell Receptors (FH-A11KRASG12V-TCR) in Treating Patients With Metastatic Solid Tumor Cancers With KRAS G12V Mutations
A Phase 1 study of Metastatic Malignant Solid Neoplasm, sponsored by Fred Hutchinson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT06043713: Recruiting Phase 1 study of Metastatic Malignant Solid Neoplasm, sponsored by Fred Hutchinson Cancer Center.
NCT06043713 is a Phase 1 study of Metastatic Malignant Solid Neoplasm that is actively recruiting participants, run by Fred Hutchinson Cancer Center. The registered enrollment target is 24 participants, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06043713, a Phase 1 study of Metastatic Malignant Solid Neoplasm, is actively recruiting participants, sponsored by Fred Hutchinson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the side effects and best dose of autologous CD8+ and CD4+ transgenic T cells expressing high affinity KRASG12V mutation-specific T cell receptors (FH-A11KRASG12V-TCR) and to see how well they work in treating patients with solid tumor cancers that has spread from where it first started (primary site) to other places in the body (metastatic). T cells are infection fighting blood cells that can kill tumor cells. The T cells given in this study will come from the patient and will have a new gene put in them that makes them able to recognize KRAS G12V, a protein on the surface of tumor cells. These KRAS G12V-specific T cells may help the body's immune system identify and kill KRAS G12V solid cancer tumor cells.
Primary Outcome
Safety and tolerability should be evaluated after each infusion. Will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0).
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy
- DRUG Bendamustine
Study Locations (1)
Washington
- Fred Hutch/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2023-12-15 |
| Est. Completion | 2028-01-01 |
| Phase | Phase 1 |
What NCT06043713 shows while recruiting
NCT06043713 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Metastatic Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT06043713 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT06043713 about?
NCT06043713 is a clinical study titled "Autologous CD8+ and CD4+ Transgenic T Cells Expressing High Affinity KRASG12V Mutation-Specific T Cell Receptors (FH-A11KRASG12V-TCR) in Treating Patients With Metastatic Solid Tumor Cancers With KRAS G12V Mutations". This phase I trial studies the side effects and best dose of autologous CD8+ and CD4+ transgenic T cells expressing high affinity KRASG12V mutation-specific T cell receptors (FH-A11KRASG12V-TCR) and to see how well they work in treating patients with solid tumor cancers that has spread from where it...
What is the current status of trial NCT06043713?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2023-12-15. Estimated completion is 2028-01-01.
What conditions does trial NCT06043713 study?
This clinical trial studies the following conditions: Metastatic Malignant Solid Neoplasm.
What interventions are being tested in trial NCT06043713?
The interventions under investigation include: Cyclophosphamide (DRUG), Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy (PROCEDURE), Bendamustine (DRUG).
Who is sponsoring clinical trial NCT06043713?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06043713 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06043713's enrollment target sits among peer trials
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