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| Name | Class |
|---|---|
| The First Affiliated Hospital of Soochow University | OTHER |
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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.
The study had a dose-escalation, open-label design. Intravenous injection of SNA006 was used to observe its safety tolerance, radiation absorbed dose, distribution, and PET imaging characteristics in patients with solid tumors. The study consists of three phases, namely, a screening period, a trial period, and a safety follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-NODAGA-SNA006 | Experimental | A PET contrast agent to assess the level of tumor tissue-infiltrating CD8 + T cells in patients with solid tumors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-NODAGA-SNA006 | Biological | A PET contrast agent to assess the level of tumor tissue-infiltrating CD8 + T cells in patients with solid tumors |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety evaluation indicators | AE/SAE/SUSAR. To observe AE/SAE/SUSAR of subjects during trial period, until 12 months after trial finished. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity evaluation | ADA blood samples were collected twice, and tested in an independent third party central laboratory. Then, ADA positive rate were analysied. | 1 week |
| Evaluation of imaging characteristics |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liyan Miao, Ph.D | The First Affiliated Hospital of Soochow University | Principal Investigator |
| Songbing Qin | The First Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39653817 | Derived | Wang 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. | |
| 35829748 |
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Target/background ratio in PET imaging of tumor lesions was calculated, compared target lesions with contralateral lesions, liver and muscle.
| 12 months |
| Evaluation of the correlation between imaging expression and immunohistochemistry | Immunohistochemical analysis (third-party independent central laboratory testing) was performed on the collected tumor tissue samples, and the scoring results were compared with the imaging expression results to calculate the sensitivity, specificity and other results. | 12 months |
| Derived |
| Wang 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. |