Pilot Phase I Study to Evaluate CD8 PET Imaging as a Marker of Immune Response to Stereotactic Body Radiation Therapy (ELIXR)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in CD8 positron emission tomography (PET) maximum standardized uptake value (SUVmax)
研究概览
简要总结
"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."
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
研究组 & 干预措施
Basic science (zirconium Zr 89-Df-crefmirlimab, PET, SBRT)
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.
干预措施: Positron Emission Tomography (Procedure)
Basic science (zirconium Zr 89-Df-crefmirlimab, PET, SBRT)
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.
干预措施: Stereotactic Body Radiation Therapy (Radiation)
Basic science (zirconium Zr 89-Df-crefmirlimab, PET, SBRT)
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.
干预措施: Zirconium Zr 89-Df-Crefmirlimab (Drug)
Basic science (zirconium Zr 89-Df-crefmirlimab, PET, SBRT)
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.
干预措施: Intensity Modulated Radiation Therapy (Radiation)
结局指标
主要结局
Change in CD8 positron emission tomography (PET) maximum standardized uptake value (SUVmax)
时间窗: 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.
次要结局
- Time evolution of CD8 PET SUV (decay corrected)(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))
- Incidence of adverse events(From the first CD8 PET tracer infusion to 4-6 weeks after the last CD8 PET tracer infusion.)
- Site specific differences in immune characterization (CD8 PET SUV) and changes(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).)
- CD8 PET SUV (Subset)(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.)
- Histology specific differences in immune characterization (CD8 PET SUV) and changes(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.(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.)