CancerPhase 1/2NCT05000372
68Ga-grazytracer PET/CT of Tumor Responses to Immunotherapy
A Phase 1/2 study testing 68Ga-grazytracer in people with Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer
- What is being tested?
- 68Ga-grazytracer
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 22 Sep 2021to 31 May 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who were diagnosed with malignant tumors;
- Patients who were scheduled to receive immunotherapy based on a decision made by a multidisciplinary team;
- participants who had no prior immunotherapy;
- participants who had no regional therapy within 3 months;
- Participants aged ≥18 years.
Who cannot join
- participants with a concurrent disease that would impede the treatment regimen;
- Participants who were unable or unwilling to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 68Ga-grazytracer PET/CT of Tumor Responses to Immunotherapy in Subjects with Solid Tumor or Lymphoma
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- 68Ga-grazytracer
- Keywords
- PET/CT, Immunotherapy, Immune checkpoint inhibition, Granzyme B, 68Ga labeling
- Medical subject headings
- Neoplasms, Lipodystrophy, Congenital Generalized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-grazytracerDrug
68Ga-grazytracer PET/CT: after intravenous injection of 2.96-3.7 MBq/kg body weight of quality-controlled 68Ga-grazytracer, a Biograph mCT Flow 64 scanner or Total-body PET/CT uEXPLORER scanner will be applied, and the scan range will be from the top of the head to 1/3 of the upper thigh.
| Study group | Role | What they receive |
|---|---|---|
| Feasibility and safety of 68Ga-grazytracer | Experimental | The purpose of the study is to evaluate the safety and early predictive performance of 68Ga-grazytracer for immunotherapy. Receives: Drug: 68Ga-grazytracer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of 68Ga-grazytracer-emergent Adverse Events
Any adverse events following the administration of the radiotracer will be monitored.
Measured: 3 year
Biodistribution of 68Ga-grazytracer
The distribution of 68Ga-grazytracer in tumors and healthy tissues will be examined through total-body dynamic PET/CT imaging.
Measured: 3 year
Analyzing the in vivo granzyme B-specificity of 68Ga-grazytracer
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.
Measured: 3 year
Assessing the early predictive value of 68Ga-grazytracer for immunotherapy response
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.
Measured: 3 year
Secondary outcomes (1)
Correlation analysis of 68Ga-grazytracer uptake and tumor immune phenotype
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.
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start22 Sep 2021
- Primary completion25 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Health Science Center
- Responsible party
- Sponsor
- Investigators
- Nan Li, M.D., Study director, Peking University Cancer Hospital & InstituteZhaofei Liu, Ph.D., Study director, Peking UniversityZhi Yang, Ph.D., Study director, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000372
- Sponsor's protocol ID
- 2021KT86
- Status last verified
- Dec 2024
- First submitted
- 27 Jul 2021
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shen X, Zhou H, Zhou X, Liu Z, Meng X, Zhang L, Song Y, Guo R, Wang F, Li K, Li W, Yang Z, Liu Z, Li N. 68Ga-grazytracer PET for noninvasive assessment of response to immunotherapy in solid tumors and lymphomas: a phase 1/2 clinical trial. Nat Commun. 2024 Oct 10;15(1):8791. doi: 10.1038/s41467-024-53197-2.
PubMed 39389969Zhou H, Wang Y, Xu H, Shen X, Zhang T, Zhou X, Zeng Y, Li K, Zhang L, Zhu H, Yang X, Li N, Yang Z, Liu Z. Noninvasive interrogation of CD8+ T cell effector function for monitoring early tumor responses to immunotherapy. J Clin Invest. 2022 Aug 15;132(16):e161065. doi: 10.1172/JCI161065.
PubMed 35788116
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 68Ga-grazytracer PET/CT of Tumor Responses to Immunotherapy in Subjects with Solid Tumor or Lymphoma
- ClinicalTrials.gov ID
- NCT05000372
- Acronym / sponsor ID
- 2021KT86
- Conditions
- Cancer
- Keywords
- PET/CT, Immunotherapy, Immune checkpoint inhibition, Granzyme B, 68Ga labeling
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Collaborators
- Peking University Health Science Center
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 25 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 11 Aug 2021 (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 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Feasibility and safety of 68Ga-grazytracer | Experimental | Drug: 68Ga-grazytracerThe purpose of the study is to evaluate the safety and early predictive performance of 68Ga-grazytracer for immunotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants who were diagnosed with malignant tumors;
- Patients who were scheduled to receive immunotherapy based on a decision made by a multidisciplinary team;
- participants who had no prior immunotherapy;
- participants who had no regional therapy within 3 months;
- Participants aged ≥18 years.
Key exclusion criteria (2 listed)
- participants with a concurrent disease that would impede the treatment regimen;
- Participants who were unable or unwilling to provide written informed consent.
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 |
|---|---|---|
| 68Ga-grazytracer68Ga-grazytracer PET/CT: after intravenous injection of 2.96-3.7 MBq/kg body weight of quality-controlled 68Ga-grazytracer, a Biograph mCT Flow 64 scanner or Total-body PET/CT uEXPLORER scanner will be applied, and the scan range will be from the top of the head to 1/3 of the upper thigh. | Drug | Feasibility and safety of 68Ga-grazytracer |
Primary outcome
Incidence of 68Ga-grazytracer-emergent Adverse Events
Time frame: 3 year
Any adverse events following the administration of the radiotracer will be monitored.
Biodistribution of 68Ga-grazytracer
Time frame: 3 year
The distribution of 68Ga-grazytracer in tumors and healthy tissues will be examined through total-body dynamic PET/CT imaging.
Analyzing the in vivo granzyme B-specificity of 68Ga-grazytracer
Time frame: 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.
Assessing the early predictive value of 68Ga-grazytracer for immunotherapy response
Time frame: 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.
1 secondary outcome
Correlation analysis of 68Ga-grazytracer uptake and tumor immune phenotype
Time frame: 3 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Derived from this study: PubMed 39389969Shen X, Zhou H, Zhou X, Liu Z, Meng X, Zhang L, Song Y, Guo R, Wang F, Li K, Li W, Yang Z, Liu Z, Li N. 68Ga-grazytracer PET for noninvasive assessment of response to immunotherapy in solid tumors and lymphomas: a phase 1/2 clinical trial. Nat Commun. 2024 Oct 10;15(1):8791. doi: 10.1038/s41467-024-53197-2.
- Derived from this study: PubMed 35788116Zhou H, Wang Y, Xu H, Shen X, Zhang T, Zhou X, Zeng Y, Li K, Zhang L, Zhu H, Yang X, Li N, Yang Z, Liu Z. Noninvasive interrogation of CD8+ T cell effector function for monitoring early tumor responses to immunotherapy. J Clin Invest. 2022 Aug 15;132(16):e161065. doi: 10.1172/JCI161065.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Nan Li, M.D. study director
Peking University Cancer Hospital & Institute
Zhaofei Liu, Ph.D. study director
Peking University
Zhi Yang, Ph.D. study director
Peking University Cancer Hospital & Institute
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 68Ga-grazytracer 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 4 Dec 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of 68Ga-grazytracer-emergent Adverse Events (time frame: 3 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05000372, which also lists 2 linked publications.
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 4 Dec 2024.