An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors (PIONEER)

Gustave Roussy

Status

Enrolling

Conditions

Hematologic Cancer

Solid Tumor, Adult

Solid Tumor, Childhood

Treatments

Procedure: Bone marrow sample

Procedure: Tumor biopsy

Procedure: Blood sample

Study type

Interventional

Funder types

Other

Identifiers

NCT05481502

2022-A00472-41

2022/3404 (Other Identifier)

Details and patient eligibility

About

This is a study to explore the phenotypic and transcriptional changes of different cellular components in the tumor following the injection of somatic cell therapy drugs.

The second objective is to explore phenotypic and transcriptional changes of different cellular components in blood and bone marrow following injection of somatic cell therapy drugs.Then correlate the phenotypic and transcriptional profile of different tumor, blood and bone marrow immune populations with clinical response and/or toxicity. And to finish this study is designed in order to identify a phenotypic, transcriptional and epigenetic profile of intra-tumoral adoptive cells and correlate this profile with clinical response and/or toxicity.

Enrollment

160 estimated patients

Sex

All

Ages

2+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient affiliated to a social security regimen
Tumor lesion accessible to core biopsies
Patient who is fully informed, able to comply with the protocol and who signed the informed consent
Pediatric patients > than 2 years old can be included
No restriction about the Eastern Cooperative Oncology Group (ECOG) status

Exclusion criteria

Coagulation abnormality prohibiting a biopsy (but patients can still give their consent for blood and bone marrow samples).
Tumor lesion not accessible to core biopsies.
Pregnant or nursing women cannot participate in this study.