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New treatment option for Metastatic Malignant Solid Neoplasm
Official title Study to Evaluate CD8 PET Imaging as a Marker of Immune Response to Stereotactic Body Radiation Therapy (ELIXR)
ClinicalTrials.gov ID: NCT05371132
What this study is testing
What is Zirconium Zr 89-Df-Crefmirlimab?
Zirconium Zr 89-Df-Crefmirlimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic malignant solid neoplasm.
Also referred to as 89Zr-Crefmirlimab Berdoxam, 89Zr-Desferrioxamine-IAB22M2C.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- "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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
See the full eligibility 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...
- Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.