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| Name | Class |
|---|---|
| Peking University Health Science Center | OTHER |
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This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the safety and clinical predictive value of 68Ga-grazytracer in subjects with solid tumor or lymphoma receiving immunotherapy.
The investigators recently developed a granzyme B-specific radiotracer named 68Ga-grazytracer. This clinical trial aims to investigate whether granzyme B PET imaging using 68Ga-grazytracer could early identify tumor responses to immune checkpoint inhibitory therapy or CAR-T therapy in subjects with solid tumor and lymphoma. PET/CT imaging of 68Ga-grazytracer will be performed in subjects after immunotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Feasibility and safety of 68Ga-grazytracer | Experimental | The purpose of the study is to evaluate the safety and early predictive performance of 68Ga-grazytracer for immunotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-grazytracer | Drug | 68Ga-grazytracer PET/CT: after intravenous injection of 2.96-3.7 MBq/kg body weight of quality-controlled 68Ga-grazytracer, a Biograph mCT Flow 64 scanner or Total-body PET/CT uEXPLORER scanner will be applied, and the scan range will be from the top of the head to 1/3 of the upper thigh. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of 68Ga-grazytracer-emergent Adverse Events | Any adverse events following the administration of the radiotracer will be monitored. | 3 year |
| Biodistribution of 68Ga-grazytracer | The distribution of 68Ga-grazytracer in tumors and healthy tissues will be examined through total-body dynamic PET/CT imaging. | 3 year |
| Analyzing the in vivo granzyme B-specificity of 68Ga-grazytracer | The specificity of 68Ga-grazytracer will be validated by correlating the immunohistochemistry results of granzyme B in either surgical or biopsy tissue samples with the standardized uptake values (SUV) of 68Ga-grazytracer in the tumors. | 3 year |
| Assessing the early predictive value of 68Ga-grazytracer for immunotherapy response | Participants will be categorized into groups with high or low 68Ga-grazytracer uptake in tumor lesions. The progression-free survival and treatment response, as assessed by RECIST 1.1 criteria, will be compared across these groups. | 3 year |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation analysis of 68Ga-grazytracer uptake and tumor immune phenotype | Participants' tumors will be classified as either "desert" or "non-desert" based on immunohistochemistry staining of CD8 from tumor samples. Subsequently, the relationship between 68Ga-grazytracer uptake and the tumors' immune phenotype will be compared. | 3 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nan Li, M.D. | Peking University Cancer Hospital & Institute | Study Director |
| Zhaofei Liu, Ph.D. | Peking University | Study Director |
| Zhi Yang, Ph.D. | Peking University Cancer Hospital & Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39389969 | Derived | Shen X, Zhou H, Zhou X, Liu Z, Meng X, Zhang L, Song Y, Guo R, Wang F, Li K, Li W, Yang Z, Liu Z, Li N. 68Ga-grazytracer PET for noninvasive assessment of response to immunotherapy in solid tumors and lymphomas: a phase 1/2 clinical trial. Nat Commun. 2024 Oct 10;15(1):8791. doi: 10.1038/s41467-024-53197-2. | |
| 35788116 | Derived |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D052497 | Lipodystrophy, Congenital Generalized |
| ID | Term |
|---|---|
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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Single Group Assignment
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|
| Zhou H, Wang Y, Xu H, Shen X, Zhang T, Zhou X, Zeng Y, Li K, Zhang L, Zhu H, Yang X, Li N, Yang Z, Liu Z. Noninvasive interrogation of CD8+ T cell effector function for monitoring early tumor responses to immunotherapy. J Clin Invest. 2022 Aug 15;132(16):e161065. doi: 10.1172/JCI161065. |
| D008060 | Lipodystrophy |
| D012875 | Skin Diseases, Metabolic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |