Clinical Trial · NCT05126927

A PET Imaging Agent to Assess the Level of Tumor Tissue-infiltrating CD8 + T Cells in Patients With Solid Tumors

Overview

Primary objective To investigate the safety and tolerability profile of 68Ga- NODAGA-SNA006 in patients with solid tumors; To investigate the radiation absorbed dose characteristics of 68Ga-NODAGA-SNA006 in patients with solid tumors; To investigate the distribution profile of 68Ga-NODAGA-SNA006 in patients with solid tumors. Secondary objectives To investigate the optimal administration dose and radiation safety profile of 68Ga-NODAGA-SNA006; To investigate the PET imaging characteristics and high-quality imaging time window of 68Ga-NODAGA-SNA006 in patients with solid tumors; To explore the correlation between PET imaging characteristics of 68Ga-NODAGA-SNA006 binding to CD8 and histological CD8 expression characteristics; To explore peripheral blood T lymphocyte differentiation (CD8, CD4, CD3, etc.) in patients with solid tumors.

Sponsor

SmartNuclide Biopharma

Phase

Early Phase 1

Contacts

Liyan Miao, Ph.D (PRINCIPAL_INVESTIGATOR)

Songbing Qin (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT05126927

Eligibility

Inclusion

Imaging results show that at least one tumor lesion can be needle biopsy or surgical treatment to obtain specimens (enhanced CT, enhanced MRI or 18F-FDG PET/CT results are acceptable);
Blood pressure measurement \< hypertension grade 1 level (including a history of hypertension, systolic blood pressure \< 140 and diastolic blood pressure \< 90 mmHg by exercise or drug treatment);
Basal heart rate 60-100 beats/min (including boundary values);
Patients with confirmed solid tumors;
Patients with immunohistochemical CD8 results within the past month;
Patients who must have at least one image-measurable lesion according to the evaluation criteria for solid tumors (RECISTv1.1);
Performance status (ECOG) score 0-1 points (see Appendix 1 for details);

Exclusion

Those who have participated in any other clinical trial within 3 months prior to screening
Those with known severe allergy to SNA006, similar drugs or excipients. Specialized conditions
Patients who have not recovered from a serious infection
Those with claustrophobia, emotional instability, acute persistent spasticity or inability to keep both arms up and lying flat for 15-30 minutes
Patients with brain metastases.
Those with comorbid major diseases or other malignancies (except those that have healed by one year or do not require additional treatment)
Those who, in the opinion of the investigator, are not suitable to participate in this clinical study.
Patients with drug/alcohol abuse, severe mental disorders
Patients who have undergone previous splenectomy or splenic disease such as hypersplenism or splenomegaly
Serum virology tests: positive results for any of hepatitis B virus surface antigen, hepatitis C virus antibodies, syphilis-specific antibodies or those who cannot be determined to be negative for human immunodeficiency virus antibodies
Those who have extremely poor nutritional status and cannot tolerate the trial
Women who are pregnant or breastfeeding.
Those who are unable to follow this clinical trial protocol well enough to make visits, or undergo relevant examinations, or treatment.