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NCT Number: NCT07724535

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, 100142, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-75 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Incidence of 18F-grazy-02-emergent Adverse Events

    Time frame: 1 year

    Any adverse events following the administration of the radiotracer will be monitored.

  2. Biodistribution of 18F-grazy-02 in participants

    Time frame: 1 year

    The distribution of 18F-grazy-02 in tumors and healthy tissues will be examined through PET/CT imaging.

Secondary outcomes

  1. Assessing 18F-grazy-02 PET for monitoring immunotherapy responses

    Time frame: 3 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Linyu Zhang

CONTACT

[email protected]

+86010-82805175

Sponsors and collaborators

Lead sponsor

Peking University Cancer Hospital & Institute

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 24, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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