Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2026-01-01 @ 12:37 PM
Study NCT ID:
NCT05371132
Status:
RECRUITING
Last Update Posted:
2025-01-14
First Post:
2022-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate CD8 PET Imaging as a Marker of Immune Response to Stereotactic Body Radiation Therapy (ELIXR)
Sponsor:
City of Hope Medical Center
Organization:
Study Overview
Official Title:
Pilot Phase I Study to Evaluate CD8 PET Imaging as a Marker of Immune Response to Stereotactic Body Radiation Therapy (ELIXR)
Status:
RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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."
Detailed Description:
PRIMARY OBJECTIVE:
I. Evaluate if there is an increase in CD8+ T cells after stereotactic body radiation therapy (SBRT) in irradiated tumors.
SECONDARY OBJECTIVES:
I. To report on the time evolution of zirconium Zr 89-Df-crefmirlimab (CD8 PET tracer) uptake after infusion.
II. To compare CD8 PET tracer uptake at irradiated lesions to uptake at non-irradiated lesions (if any).
III. To assess how differences in site, histology and/or prior therapy relate to immune characterization and changes IV. To assess serum biomarkers of immune response before and after SBRT. V. To assess ability of CD8 PET tracer and imaging to be a biomarker of SBRT. VI. Evaluate CD8 PET tracer with Response Evaluation Criteria in Solid Tumors (RECIST) radiology measurements.
VII. To report any adverse events associated with 2 doses of CD8 PET tracer when used in combination with SBRT.
EXPLORATORY OBJECTIVE:
I. Blood will be collected, processed, and stored for future immune profiling or other correlatives pending additional funding.
II. Evaluate the safety and feasibility of using CD8 PET imaging to assess immune system activation during and after bRT for CAR T cell therapy.
III. Describe the CD8 PET tracer uptake prior to CAR T and the response/duration of response to CAR T cell therapy
OUTLINE:
Patients receive zirconium Zr 89-Df-crefmirlimab intravenously (IV) over 5-10 minutes and then undergo PET imaging 24 hours after infusion before and after SBRT. Patients undergo SBRT every 2-5 days for a total of 5 fractions.
The subset of lymphoma patients enrolled on trial who are being treated in the bridging radiation setting before CAR T-cell therapy will receive 3 infusions of Zr89-Df-crefmirlimab and associated CD8 ImmunoPET imaging before radiation, after radiation, and after CAR T-cell infusion.
After completion of study treatment, patients are followed up at 4-6 weeks, 3 months, 1 year, and then periodically for 2 years.
I. Evaluate if there is an increase in CD8+ T cells after stereotactic body radiation therapy (SBRT) in irradiated tumors.
SECONDARY OBJECTIVES:
I. To report on the time evolution of zirconium Zr 89-Df-crefmirlimab (CD8 PET tracer) uptake after infusion.
II. To compare CD8 PET tracer uptake at irradiated lesions to uptake at non-irradiated lesions (if any).
III. To assess how differences in site, histology and/or prior therapy relate to immune characterization and changes IV. To assess serum biomarkers of immune response before and after SBRT. V. To assess ability of CD8 PET tracer and imaging to be a biomarker of SBRT. VI. Evaluate CD8 PET tracer with Response Evaluation Criteria in Solid Tumors (RECIST) radiology measurements.
VII. To report any adverse events associated with 2 doses of CD8 PET tracer when used in combination with SBRT.
EXPLORATORY OBJECTIVE:
I. Blood will be collected, processed, and stored for future immune profiling or other correlatives pending additional funding.
II. Evaluate the safety and feasibility of using CD8 PET imaging to assess immune system activation during and after bRT for CAR T cell therapy.
III. Describe the CD8 PET tracer uptake prior to CAR T and the response/duration of response to CAR T cell therapy
OUTLINE:
Patients receive zirconium Zr 89-Df-crefmirlimab intravenously (IV) over 5-10 minutes and then undergo PET imaging 24 hours after infusion before and after SBRT. Patients undergo SBRT every 2-5 days for a total of 5 fractions.
The subset of lymphoma patients enrolled on trial who are being treated in the bridging radiation setting before CAR T-cell therapy will receive 3 infusions of Zr89-Df-crefmirlimab and associated CD8 ImmunoPET imaging before radiation, after radiation, and after CAR T-cell infusion.
After completion of study treatment, patients are followed up at 4-6 weeks, 3 months, 1 year, and then periodically for 2 years.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2022-02037 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 21221 | OTHER | City of Hope Medical Center | View | |
| P30CA033572 | NIH | None | https://reporter.nih.gov/quic… | View |