18F-grazy-02 PET/CT of Granzyme B Expression for Monitoring Immunotherapy

18F-grazy-02 PET/CT of Granzyme B Expression for Monitoring Immunotherapy in Patients With Lymphoma or Solid Tumors

This is an open-label PET/CT study to investigate the safety and clinical monitoring value of 18F-grazy-02 in patients with lymphoma or solid tumors receiving immunotherapy, including immune checkpoint inhibition and CAR-T cell therapy.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer
• Intervention / Treatment: Drug: 18F-grazy-02

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Linyu Zhang; Phone Number: +86010-82805175; Email: zhanglinyu1@pku.edu.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Peking University Cancer Hospital & Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 18-75 years old;
2. ECOG score 0 or 1 point;
3. Participants with suspected or confirmed non-small cell lung cancer or melanoma who are suggested by the clinicians to conduct PET/CT imaging for tumor diagnosis or staging.

Exclusion Criteria:

1. Pregnant or nursing;
2. Severe hepatic or renal dysfunction;
3. Low WBC (less than 3 x 10^9/L);
4. Unable to comply with the PET/CT imaging procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental 18F-grazy-02 PET/CT imaging; The purpose of the study is to evaluate the safety and early monitoring performance of 18F-grazy-02 for immunotherapy.	Drug: 18F-grazy-02; 18F-grazy-02 PET/CT: after intravenous injection of 2.96-3.7 MBq/kg body weight of quality-controlled 18F-grazy-02 , a Total-body PET/CT uEXPLORER scanner will be applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of 18F-grazy-02-emergent Adverse Events	Any adverse events following the administration of the radiotracer will be monitored.	1 year
Biodistribution of 18F-grazy-02 in participants	The distribution of 18F-grazy-02 in tumors and healthy tissues will be examined through PET/CT imaging.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing 18F-grazy-02 PET for monitoring immunotherapy responses	Participants will be categorized into groups with high or low 18F-grazy-02 uptake in tumor lesions. Therapy efficacy of immunotherapy as assessed by RECIST 1.1 will be compared across these two groups.	3 years

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Estimated): June 24, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: June 30, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 2021KT86-ZY01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not plan to share individual participant data due to protect participant privacy. Although data are not shared publicly, requests for de-identified data may be considered on a case-by-case basis by contacting the principal investigator at email.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No