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NCT05371132 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate CD8 PET Imaging as a Marker of Immune Response to Stereotactic Body Radiation Therapy (ELIXR)
A Phase 1 study of Lymphoma and Metastatic Malignant Solid Neoplasm, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT05371132: Recruiting Phase 1 study of Lymphoma and Metastatic Malignant Solid Neoplasm, sponsored by City of Hope Medical Center.
NCT05371132 is a Phase 1 study of Lymphoma and Metastatic Malignant Solid Neoplasm that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 10 participants, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05371132, a Phase 1 study of Lymphoma and Metastatic Malignant Solid Neoplasm, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
"This phase I trial investigates the effect of radiation therapy on the immune system, specifically CD8 positive (+) T cells, in lymphoma patients receiving bridging radiation therapy before CAR T-cell infusion, and metastatic patients with solid tumor malignancies receiving SBRT. CD8+ T cells are mainly found in lymph tissue and play a significant role in anti-tumor immunity. These cells can infiltrate tumor cells and kill them. Radiation therapy may recruit CD8 T cells and this recruitment may help with tumor control. Diagnostic procedures, such as zirconium Zr 89-Df-crefmirlimab positron emission tomography (PET), may be a less invasive way to check and monitor for CD8+ T cells before and after radiation therapy."
Primary Outcome
CD8 PET SUV will be measured as SUVmax, the maximum SUV measurement within the tumor voxels. If patients have multiple tumors treated with stereotactic body radiation therapy (SBRT), average within-tumor change will be used for that patient for the primary analysis. As a result, this primary analysis is a comparison of the change in CD8 PET SUV in 10 patients.
Conditions Studied
Interventions
- PROCEDURE Positron Emission Tomography
- RADIATION Stereotactic Body Radiation Therapy
- RADIATION Intensity Modulated Radiation Therapy
- DRUG Zirconium Zr 89-Df-Crefmirlimab
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2022-06-20 |
| Est. Completion | 2026-10-05 |
| Phase | Phase 1 |
What NCT05371132 shows while recruiting
NCT05371132 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Lymphoma appearing as the primary indexed condition, and to 4 interventions - of which Positron Emission Tomography is the first listed.
NCT05371132 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05371132 about?
NCT05371132 is a clinical study titled "Study to Evaluate CD8 PET Imaging as a Marker of Immune Response to Stereotactic Body Radiation Therapy (ELIXR)". "This phase I trial investigates the effect of radiation therapy on the immune system, specifically CD8 positive (+) T cells, in lymphoma patients receiving bridging radiation therapy before CAR T-cell infusion, and metastatic patients with solid tumor malignancies receiving SBRT. CD8+ T cells are m...
What is the current status of trial NCT05371132?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2022-06-20. Estimated completion is 2026-10-05.
What conditions does trial NCT05371132 study?
This clinical trial studies the following conditions: Lymphoma, Metastatic Malignant Solid Neoplasm.
What interventions are being tested in trial NCT05371132?
The interventions under investigation include: Positron Emission Tomography (PROCEDURE), Stereotactic Body Radiation Therapy (RADIATION), Intensity Modulated Radiation Therapy (RADIATION), Zirconium Zr 89-Df-Crefmirlimab (DRUG).
Who is sponsoring clinical trial NCT05371132?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05371132 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05371132's enrollment target sits among peer trials
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