Evaluating CD8 PET Imaging for Immune Response in Cancer Treatment
Pilot Phase I Study to Evaluate CD8 PET Imaging as a Marker of Immune Response to Stereotactic Body Radiation Therapy (ELIXR)
This study is testing if a special type of radiation therapy can boost immune cells in patients with lymphoma and solid tumors, while also checking if a new imaging method can safely track these changes.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | radiation, crefmirlimab, CAR T |
| Locations | 1 site (Duarte, California) |
| Trial ID | NCT05371132 on ClinicalTrials.gov |
What this trial studies
This phase I trial investigates how stereotactic body radiation therapy (SBRT) affects CD8 positive T cells in patients with lymphoma and metastatic solid tumors. The study aims to determine if radiation therapy can increase the presence of these immune cells, which are crucial for fighting tumors. Participants will receive a CD8 PET tracer before and after SBRT to monitor changes in T cell activity. The trial also explores the safety and feasibility of using this imaging technique as a biomarker for immune response during treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with metastatic solid tumors or lymphoma who are eligible for SBRT.
Not a fit: Patients with significant comorbidities or those unable to comply with the study procedures may not benefit from this trial.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of immune responses to radiation therapy, potentially improving treatment outcomes for cancer patients.
How similar studies have performed: While the use of CD8 PET imaging is a novel approach, similar studies have shown promise in understanding immune responses in cancer treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) * 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) Exclusion Criteria: * 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)
Where this trial is running
Duarte, California
- City of Hope Medical Center — Duarte, California, United States (Recruiting)
Study contacts
- Principal investigator: Savita V Dandapani — City of Hope Medical Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.