CancerPhase 1/2NCT07724535
18F-grazy-02 PET/CT of Granzyme B Expression for Monitoring Immunotherapy
A Phase 1/2 study testing 18F-grazy-02 in people with Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- 18F-grazy-02
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 24 Jun 2026to 31 Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, 100142
About this study
Official title: 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.
- Conditions
- Cancer
- Being tested
- 18F-grazy-02
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-grazy-02Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: 18F-grazy-02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of 18F-grazy-02-emergent Adverse Events
Any adverse events following the administration of the radiotracer will be monitored.
Measured: 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.
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start24 Jun 2026
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nan Li, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07724535
- Sponsor's protocol ID
- 2021KT86-ZY01
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-grazy-02 PET/CT of Granzyme B Expression for Monitoring Immunotherapy in Patients With Lymphoma or Solid Tumors
- ClinicalTrials.gov ID
- NCT07724535
- Acronym / sponsor ID
- 2021KT86-ZY01
- Conditions
- Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 24 Jun 2026 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental 18F-grazy-02 PET/CT imaging | Experimental | Drug: 18F-grazy-02The purpose of the study is to evaluate the safety and early monitoring performance of 18F-grazy-02 for immunotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-grazy-0218F-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. | Drug | experimental 18F-grazy-02 PET/CT imaging |
Primary outcome
Incidence of 18F-grazy-02-emergent Adverse Events
Time frame: 1 year
Any adverse events following the administration of the radiotracer will be monitored.
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.
1 secondary outcome
Assessing 18F-grazy-02 PET for monitoring immunotherapy responses
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 18F-grazy-02 in people with Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linyu Zhang (+86010-82805175, zhanglinyu1@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of 18F-grazy-02-emergent Adverse Events (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.