Clinical trial · Interventional
A PET Imaging Agent to Assess the Level of Tumor Tissue-infiltrating CD8 + T Cells in Patients With Solid Tumors
A Study to Evaluate the Safety Tolerability, Radiation Absorbed Dose,Distribution, PET Imaging and Histological Expression of 68GA-Nodaga-SNA006 in Patients With Solid Tumors.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-NODAGA-SNA006 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-NODAGA-SNA006
- description
- A PET contrast agent to assess the level of tumor tissue-infiltrating CD8 + T cells in patients with solid tumors
- interventionNames
- Biological: 68Ga-NODAGA-SNA006
Primary outcomes (1)
- measure
- Safety evaluation indicators
- timeFrame
- 12 months
- description
- AE/SAE/SUSAR. To observe AE/SAE/SUSAR of subjects during trial period, until 12 months after trial finished.
Secondary outcomes (3)
- measure
- Immunogenicity evaluation
- timeFrame
- 1 week
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18-70 years (including boundary values); 2. Have behavioral ability, and voluntarily participate in this clinical study, and sign the informed consent form (ICF); 3. Performance status (ECOG) score 0-1 points (see Appendix 1 for details); 4. Basal heart rate 60-100 beats/min (including boundary values); 5. 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); 6. Patients with confirmed solid tumors; 7. Patients who must have at least one image-measurable lesion according to the evaluation criteria for solid tumors (RECISTv1.1); 8. 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); 9. Patients with immunohistochemical CD8 results within the past month; Exclusion Criteria: 1. Those who are unable to follow this clinical trial protocol well enough to make visits, or undergo relevant examinations, or treatment. 2. Those who have extremely poor nutritional status and cannot tolerate the trial 3. Those with comorbid major diseases or other malignancies (except those that have healed by one year or do not require additional treatment) 4. Those with known severe allergy to SNA006, similar drugs or excipients. Specialized conditions 5. Patients who have undergone previous splenectomy or splenic disease such as hypersplenism or splenomegaly 6. Patients with brain metastases. 7. 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 8. Patients who have not recovered from a serious infection 9. Patients with drug/alcohol abuse, severe mental disorders 10. Those with claustrophobia, emotional instability, acute persistent spasticity or inability to keep both arms up and lying flat for 15-30 minutes 11. Those who have participated in any other clinical trial within 3 months prior to screening 12. Women who are pregnant or breastfeeding. 13. Those who, in the opinion of the investigator, are not suitable to participate in this clinical study.
References
Publications (2)
- DERIVEDWang Y, Zheng M, Zhao J, Wang C, Zhao S, Bian Y, Dai N, Zheng Y, Sang S, Guo L, Huang C, Zhang H, Jiang J, Xu C, Zhao Q, Han J, Xu T, Qin S, Miao L. Human dose-escalation study of PET imaging CD8+ T-cell infiltration in solid malignancies with [68Ga]Ga -NODAGA-SNA006. Eur J Nucl Med Mol Imaging. 2025 Mar;52(4):1332-1344. doi: 10.1007/s00259-024-06999-x. Epub 2024 Dec 10. PMID 39653817
- DERIVEDWang Y, Wang C, Huang M, Qin S, Zhao J, Sang S, Zheng M, Bian Y, Huang C, Zhang H, Guo L, Jiang J, Xu C, Dai N, Zheng Y, Han J, Yang M, Xu T, Miao L. Pilot study of a novel nanobody 68 Ga-NODAGA-SNA006 for instant PET imaging of CD8+ T cells. Eur J Nucl Med Mol Imaging. 2022 Nov;49(13):4394-4405. doi: 10.1007/s00259-022-05903-9. Epub 2022 Jul 13. PMID 35829748