68Ga-grazytracer PET/CT of Tumor Responses to Immunotherapy

Phase 1

Completed

• Conditions: Cancer
• Interventions: Drug: 68Ga-grazytracer

• Registration Number: NCT05000372
• Lead Sponsor: Peking University Cancer Hospital & Institute

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-07-27
• Study First Submitted QC: 2021-08-03
• Study First Posted: 2021-08-11
• Study Start: 2021-09-22
• Primary Completion: 2024-05-25
• Study Completion: 2024-05-31
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Participants who were diagnosed with malignant tumors;
2. Patients who were scheduled to receive immunotherapy based on a decision made by a multidisciplinary team;
3. participants who had no prior immunotherapy;
4. participants who had no regional therapy within 3 months;
5. Participants aged ≥18 years.

Exclusion Criteria

1. participants with a concurrent disease that would impede the treatment regimen;
2. Participants who were unable or unwilling to provide written informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Feasibility and safety of 68Ga-grazytracer	68Ga-grazytracer	The purpose of the study is to evaluate the safety and early predictive performance of 68Ga-grazytracer for immunotherapy.

Primary Outcome Measures

Name	Time	Method
Biodistribution of 68Ga-grazytracer	3 year	The distribution of 68Ga-grazytracer in tumors and healthy tissues will be examined through total-body dynamic PET/CT imaging.
Incidence of 68Ga-grazytracer-emergent Adverse Events	3 year	Any adverse events following the administration of the radiotracer will be monitored.
Assessing the early predictive value of 68Ga-grazytracer for immunotherapy response	3 year	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.
Analyzing the in vivo granzyme B-specificity of 68Ga-grazytracer	3 year	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.

Secondary Outcome Measures

Name	Time	Method
Correlation analysis of 68Ga-grazytracer uptake and tumor immune phenotype	3 year	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.

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China