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

NCT05126927 | Completed Early Phase 1

• 1 other identifier: SN-2021-01
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Safety evaluation indicators

  AE/SAE/SUSAR. To observe AE/SAE/SUSAR of subjects during trial period, until 12 months after trial finished.

  12 months

Secondary Outcomes (3)

• Immunogenicity evaluation

  1 week

• Evaluation of imaging characteristics

  12 months

• Evaluation of the correlation between imaging expression and immunohistochemistry

  12 months

Study Arms (1)

68Ga-NODAGA-SNA006

EXPERIMENTAL

A PET contrast agent to assess the level of tumor tissue-infiltrating CD8 + T cells in patients with solid tumors

Biological: 68Ga-NODAGA-SNA006

Interventions

68Ga-NODAGA-SNA006 BIOLOGICAL

A PET contrast agent to assess the level of tumor tissue-infiltrating CD8 + T cells in patients with solid tumors

68Ga-NODAGA-SNA006

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 years (including boundary values);
• Have behavioral ability, and voluntarily participate in this clinical study, and sign the informed consent form (ICF);
• Performance status (ECOG) score 0-1 points (see Appendix 1 for details);
• Basal heart rate 60-100 beats/min (including boundary values);
• 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);
• Patients with confirmed solid tumors;
• Patients who must have at least one image-measurable lesion according to the evaluation criteria for solid tumors (RECISTv1.1);
• 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);
• Patients with immunohistochemical CD8 results within the past month;

You may not qualify if:

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

Sponsors & Collaborators

• SmartNuclide Biopharma: lead
• The First Affiliated Hospital of Soochow University: collaborator

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location

Related Publications (2)

• 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.

  PMID: 39653817 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.

  PMID: 35829748 DERIVED

Study Officials

• Liyan Miao, Ph.D

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

• Songbing Qin

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 19, 2021
• Study Start: November 2, 2021
• Primary Completion: January 19, 2022
• Study Completion: August 1, 2022
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)