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

P

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)

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

Trial contacts and locations

1

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Central trial contact

Haoyi Zhou

Data sourced from clinicaltrials.gov

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