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NCT Number: NCT05481502

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

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.

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Key information

Conditions

Solid Tumor, Adult Hematologic Cancer Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site Solid Tumor, Childhood

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tumor Biopsy

Procedure

3 biopsies will be collected: at baseline, at day+15 and optionally at relapse

Blood sample

Procedure

7 blood samples (25ml) will be taken: at day-7 before treatment start, at day0, at day+3, day+7, day+15, month+3 and at relapse

bone marrow sample

Procedure

If a bone marrow biopsy or aspiration is performed as part of routine care, 1 mL of bone marrow aspiration or one more biopsy will be sampled

Primary outcomes

  1. Comparison of frequency, phenotype and transcriptional profile of the different immune subsets in the tumor following adoptive cell therapy infusion using spectral flow cytometry and RNA sequencing

    Time frame: 3 months following ACT

Secondary outcomes

  1. Objective Response

    Time frame: 3 months following ACT

    Defined by RECIST 1.1 score for lymphoma and solid tumors

  2. Progression-free survival

    Time frame: 5 years after first ACT infusion

    Defined as the time between the adoptive cell therapy and progression, or death whatever the cause, whichever occurs first.

  3. Overall survival

    Time frame: 5 years after first ACT infusion

    Defined as the time between the adoptive cell therapy injection and death whatever the cause

  4. Safety of biopsies procedures (when applicable) graded according to CTCAE v5.0

    Time frame: From enrollment to 30 days after the last sample

Study contacts

Contact information is provided by the study sponsor or research team.

Camille BIGENWALD, MD

CONTACT

[email protected]

+33 (0)1 42 11 42 29

Cristina CASTILLA LLORENTE, MD

CONTACT

[email protected]

+33 (0)1 42 11 42 39

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Registry information

Official study title

A Prospective Trial to Evaluate Immune Determinants of the Response and the Toxicity to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors

Acronym: PIONEER

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Aug 1, 2022
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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