68Ga-grazytracer PET/CT of Tumor Responses to Immunotherapy

Peking University Cancer Hospital & Institute

Status and phase: Completed; Phase 2; Phase 1

Conditions: Cancer

Treatments: Drug: 68Ga-grazytracer

Study type: Interventional

Funder types: Other

Identifiers

NCT05000372

2021KT86

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Feasibility and safety of 68Ga-grazytracer

Experimental group

Description:

The purpose of the study is to evaluate the safety and early predictive performance of 68Ga-grazytracer for immunotherapy.

Treatment:

Drug: 68Ga-grazytracer