Metastatic Malignant Solid NeoplasmPhase 1NCT05371132
Study to Evaluate CD8 PET Imaging as a Marker of Immune Response to Stereotactic Body Radiation Therapy (ELIXR)
A Phase 1 study testing Positron Emission Tomography, Stereotactic Body Radiation Therapy and Zirconium Zr 89-Df-Crefmirlimab in people with Metastatic Malignant Solid Neoplasm and Lymphoma, run by City of Hope Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Malignant Solid Neoplasm, Lymphoma
- What is being tested?
- Positron Emission Tomography, Stereotactic Body Radiation Therapy and Zirconium Zr 89-Df-Crefmirlimab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2022to 5 Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented informed consent of the participant and/or legally authorized representative
- Participant is willing and able to comply with all protocol required procedures
- Age: >= 18 years
- Eastern Cooperative Oncology Group (ECOG) =< 2
- Metastatic patients of any solid tumor malignancy amenable for SBRT as determined by the radiation oncologist
- Lymphoma patients may be allowed as determined by the principal investigator (PI)
Show all 13Show fewer
- No change in systemic treatment regimen for past 2 months prior to start of SBRT
- Patients able to comply with daily PET after SBRT
- Patient meets all clinical safety lab values per institution's standard of care, or Investigator's discretion, for patients receiving cancer treatment
- Women of childbearing potential (WOCBP): negative urine or serum pregnancy test
- If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- Agreement by females and males of childbearing potential to use effective double barrier contraceptive methods or abstain from heterosexual activity for the course of the study through at least 30 days after the last administration of the CD8 PET tracer
- Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)
Who cannot join
- Patient who have splenic disorders or had splenectomy that per PI would interfere with CD8 imaging
- Patients should not have any uncontrolled illness including ongoing or active infection
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to CD8 PET tracer
- Serious nonmalignant disease or conditions that could compromise protocol objectives, in the opinion of the investigator
- Females only: Pregnant or breastfeeding
- Pregnant women are excluded from this study because CD8 PET tracer is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CD8 PET tracer, breastfeeding should be discontinued if the mother is treated with CD8 PET tracer
- Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
Savita V. Dandapani, 626-359-8111, sdandapani@coh.org
Savita V. Dandapani
About this study
Official title: Pilot Phase I 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 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."
Read the detailed description
PRIMARY OBJECTIVE:
- Evaluate if there is an increase in CD8+ T cells after stereotactic body radiation therapy (SBRT) in irradiated tumors.
SECONDARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Metastatic Malignant Solid Neoplasm, Lymphoma
- Being tested
- Positron Emission Tomography, Stereotactic Body Radiation Therapy, Zirconium Zr 89-Df-Crefmirlimab, Intensity Modulated Radiation Therapy
- Medical subject headings
- Neoplasm Metastasis, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan
Undergo PET
Stereotactic Body Radiation TherapyRadiation
Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Undergo SBRT
Zirconium Zr 89-Df-CrefmirlimabDrug
Also called 89Zr-Crefmirlimab Berdoxam, 89Zr-Desferrioxamine-IAB22M2C, 89Zr-Df-Crefmirlimab, 89Zr-Df-IAB22M2C
Given IV
Intensity Modulated Radiation TherapyRadiation
Also called IMRT
IMRT for Lymphoma patients only
| Study group | Role | What they receive |
|---|---|---|
| Basic science (zirconium Zr 89-Df-crefmirlimab, PET, SBRT) | Experimental | Patients receive zirconium Zr 89-Df-crefmirlimab IV over 5-10 minutes and then under PET imaging 24 hours after infusion before and after SBRT. Patients undergo SBRT every 2-5 days for a total of 5 fractions. For lymphoma patients only, IMRT on consecutive days may be used. Receives: Procedure: Positron Emission Tomography; Radiation: Stereotactic Body Radiation Therapy; Drug: Zirconium Zr 89-Df-Crefmirlimab; Radiation: Intensity Modulated Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CD8 positron emission tomography (PET) maximum standardized uptake value (SUVmax)
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.
Measured: Pre-SBRT to post-SBRT (comparison of CD8 PET SUV at day -1, and at 1 week after completion of SBRT)
Secondary outcomes (6)
Time evolution of CD8 PET SUV (decay corrected)
CD8 PET SUVs from PET scans taken before, during and after SBRT.
Measured: From pre-SBRT to post-SBRT (comparison of CD8 PET SUV at day -1, and at each of 5 fractions of SBRT administered 2-5 days apart, and additional imaging 1-2 weeks after completion of SBRT)
Site specific differences in immune characterization (CD8 PET SUV) and changes
CD8 PET SUV and change in CD8 PET SUV at tumor sites will be collected to assess whether immune activity and response is different at different sites of disease (e.g., lymph node vs bone)
Measured: From pre-SBRT to post-SBRT ( CD8 PET SUV at day -1, and at each of 5 fractions of SBRT administered 2-5 days apart, and additional imaging 1-2 weeks after completion of SBRT).
Histology specific differences in immune characterization (CD8 PET SUV) and changes
CD8 PET SUV and change in CD8 PET SUV will be collected to assess whether immune activity and response is different depending on the patient's disease type and histopathology.
Measured: From pre-SBRT to post-SBRT ( CD8 PET SUV at day -1, and at each of 5 fractions of SBRT administered 2-5 days apart, and additional imaging 1-2 weeks after completion of SBRT).
Evaluation of tumor response (fludeoxyglucose F-18 [FDG] PET and/or computed tomography [CT]) as it relates to both baseline CD8 PET SUV and changes observed after SBRT.
RECIST response and evaluation endpoints will be used to assess tumor response from CT imaging, and SUVmax will be used for FDG-PET imaging. Data will be compared with CD8 PET SUVs (e.g. SUVmax of CD8 PET) and changes pre- and post-SBRT. For multiple lesions irradiated SUVmax will be averaged.
Measured: Pre-SBRT to post-SBRT (1-2 weeks after completion of SBRT). Additional RECIST response assessments will be conducted per standard of care and will be assessed for up to 2 years to compare to CD8 SUVs post-SBRT and changes in CD8 SUVs.
CD8 PET SUV (Subset)
Will describe CD8 PET SUV in the subset (approximately 2 patients) who receive CAR-T therapy, and those patients' response/duration of response to CAR-T. CD8 PET SUVs from PET scans taken before, during and after bridging radiation, as well as after CAR T cell therapy. Response to radiation and CAR T and survival after the combination treatment will be collected and compared to CD8 uptake patterns.
Measured: Pre-bridging radiation to post-CAR T cell therapy (approximately at least 7 days after CAR T cell infusion). Additional response and survival data will be collected up to 2 years after completion of study therapy.
Incidence of adverse events
Number and type of adverse events related to the study treatment
Measured: From the first CD8 PET tracer infusion to 4-6 weeks after the last CD8 PET tracer infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start20 Jun 2022
- Primary completion5 Oct 2026 (estimated)
- Study completion5 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Malignant Solid NeoplasmStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Savita V Dandapani, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371132
- Sponsor's protocol ID
- 21221
- Other IDs
- NCI-2022-02037, 21221, P30CA033572
- Status last verified
- Jan 2026
- First submitted
- 24 Mar 2022
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Phase I Study to Evaluate CD8 PET Imaging as a Marker of Immune Response to Stereotactic Body Radiation Therapy (ELIXR)
- ClinicalTrials.gov ID
- NCT05371132
- Acronym / sponsor ID
- 21221
- Conditions
- Metastatic Malignant Solid Neoplasm, Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 5 Oct 2026 (estimated)
- Study completion
- 5 Oct 2026 (estimated)
- First posted
- 12 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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:
- Evaluate if there is an increase in CD8+ T cells after stereotactic body radiation therapy (SBRT) in irradiated tumors.
SECONDARY OBJECTIVES:
- 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:
- 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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Basic science (zirconium Zr 89-Df-crefmirlimab, PET, SBRT) | Experimental | Procedure: Positron Emission Tomography, Radiation: Stereotactic Body Radiation Therapy, Drug: Zirconium Zr 89-Df-Crefmirlimab, Radiation: Intensity Modulated Radiation TherapyPatients receive zirconium Zr 89-Df-crefmirlimab IV over 5-10 minutes and then under PET imaging 24 hours after infusion before and after SBRT. Patients undergo SBRT every 2-5 days for a total of 5 fractions. For lymphoma patients only, IMRT on consecutive days may be used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Documented informed consent of the participant and/or legally authorized representative
- Participant is willing and able to comply with all protocol required procedures
- Age: >= 18 years
- Eastern Cooperative Oncology Group (ECOG) =< 2
- Metastatic patients of any solid tumor malignancy amenable for SBRT as determined by the radiation oncologist
Key exclusion criteria (8 listed)
- Patient who have splenic disorders or had splenectomy that per PI would interfere with CD8 imaging
- Patients should not have any uncontrolled illness including ongoing or active infection
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to CD8 PET tracer
- Serious nonmalignant disease or conditions that could compromise protocol objectives, in the opinion of the investigator
- Females only: Pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography ScanUndergo PET | Procedure or surgery | Basic science (zirconium Zr 89-Df-crefmirlimab, PET, SBRT) |
| Stereotactic Body Radiation TherapyAlso: SABR, SBRT, Stereotactic Ablative Body Radiation TherapyUndergo SBRT | Radiation | Basic science (zirconium Zr 89-Df-crefmirlimab, PET, SBRT) |
| Zirconium Zr 89-Df-CrefmirlimabAlso: 89Zr-Crefmirlimab Berdoxam, 89Zr-Desferrioxamine-IAB22M2C, 89Zr-Df-Crefmirlimab, 89Zr-Df-IAB22M2CGiven IV | Drug | Basic science (zirconium Zr 89-Df-crefmirlimab, PET, SBRT) |
| Intensity Modulated Radiation TherapyAlso: IMRTIMRT for Lymphoma patients only | Radiation | Basic science (zirconium Zr 89-Df-crefmirlimab, PET, SBRT) |
Primary outcome
Change in CD8 positron emission tomography (PET) maximum standardized uptake value (SUVmax)
Time frame: Pre-SBRT to post-SBRT (comparison of CD8 PET SUV at day -1, and at 1 week after completion of SBRT)
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.
6 secondary outcomes
Time evolution of CD8 PET SUV (decay corrected)
Time frame: From pre-SBRT to post-SBRT (comparison of CD8 PET SUV at day -1, and at each of 5 fractions of SBRT administered 2-5 days apart, and additional imaging 1-2 weeks after completion of SBRT)
Site specific differences in immune characterization (CD8 PET SUV) and changes
Time frame: From pre-SBRT to post-SBRT ( CD8 PET SUV at day -1, and at each of 5 fractions of SBRT administered 2-5 days apart, and additional imaging 1-2 weeks after completion of SBRT).
Histology specific differences in immune characterization (CD8 PET SUV) and changes
Time frame: From pre-SBRT to post-SBRT ( CD8 PET SUV at day -1, and at each of 5 fractions of SBRT administered 2-5 days apart, and additional imaging 1-2 weeks after completion of SBRT).
Evaluation of tumor response (fludeoxyglucose F-18 [FDG] PET and/or computed tomography [CT]) as it relates to both baseline CD8 PET SUV and changes observed after SBRT.
Time frame: Pre-SBRT to post-SBRT (1-2 weeks after completion of SBRT). Additional RECIST response assessments will be conducted per standard of care and will be assessed for up to 2 years to compare to CD8 SUVs post-SBRT and changes in CD8 SUVs.
CD8 PET SUV (Subset)
Time frame: Pre-bridging radiation to post-CAR T cell therapy (approximately at least 7 days after CAR T cell infusion). Additional response and survival data will be collected up to 2 years after completion of study therapy.
Incidence of adverse events
Time frame: From the first CD8 PET tracer infusion to 4-6 weeks after the last CD8 PET tracer infusion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Savita V Dandapani principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Positron Emission Tomography, Stereotactic Body Radiation Therapy and Zirconium Zr 89-Df-Crefmirlimab in people with Metastatic Malignant Solid Neoplasm and Lymphoma, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CD8 positron emission tomography (PET) maximum standardized uptake value (SUVmax) (time frame: Pre-SBRT to post-SBRT (comparison of CD8 PET SUV at day -1, and at 1 week after completion of SBRT)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.