Clinical trial NCT05000372: 68Ga-grazytracer PET/CT of Tumor Responses to Immunotherapy
Official title: 68Ga-grazytracer PET/CT of Tumor Responses to Immunotherapy in Subjects with Solid Tumor or Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cancer
Keywords: PET/CT
Immunotherapy
Immune checkpoint inhibition
Granzyme B
68Ga labeling
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
Collaborators: name: Peking University Health Science Center
First posted: 2021-08-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Single Group Assignment
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Participants who were diagnosed with malignant tumors;
2. Patients who were scheduled to receive immunotherapy based on a decision made by a multidisciplinary team;
3. participants who had no prior immunotherapy;
4. participants who had no regional therapy within 3 months;
5. Participants aged ≥18 years.

Exclusion Criteria:

1. participants with a concurrent disease that would impede the treatment regimen;
2. Participants who were unable or unwilling to provide written informed consent.

Primary outcomes:
measure: Incidence of 68Ga-grazytracer-emergent Adverse Events
timeFrame: 3 year
measure: Biodistribution of 68Ga-grazytracer
timeFrame: 3 year
measure: Analyzing the in vivo granzyme B-specificity of 68Ga-grazytracer
timeFrame: 3 year
measure: Assessing the early predictive value of 68Ga-grazytracer for immunotherapy response
timeFrame: 3 year
Secondary outcomes:
measure: Correlation analysis of 68Ga-grazytracer uptake and tumor immune phenotype
timeFrame: 3 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Nan Li, M.D.
role: STUDY_DIRECTOR
affiliation: Peking University
name: Zhaofei Liu, Ph.D.
role: STUDY_DIRECTOR
affiliation: Peking University Cancer Hospital & Institute
name: Zhi Yang, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Zhou 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.