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

NCT07724535 | Recruiting Phase 1

• 1 other identifier: 2021KT86-ZY01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Assessing 18F-grazy-02 PET for monitoring immunotherapy responses

  3 years

Study Arms (1)

experimental 18F-grazy-02 PET/CT imaging

EXPERIMENTAL

The purpose of the study is to evaluate the safety and early monitoring performance of 18F-grazy-02 for immunotherapy.

Drug: 18F-grazy-02

Interventions

18F-grazy-02 DRUG

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.

experimental 18F-grazy-02 PET/CT imaging

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old;
• ECOG score 0 or 1 point;
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Linyu Zhang

CONTACT

+86010-82805175; zhanglinyu1@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 24, 2026
• Study Start: June 24, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 31, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)