NCT05481502

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Jun 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Jun 2022Jul 2027

Study Start

First participant enrolled

June 8, 2022

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 1, 2022

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

June 24, 2025

Status Verified

June 1, 2025

Enrollment Period

5.1 years

First QC Date

June 24, 2022

Last Update Submit

June 23, 2025

Conditions

Solid Tumor, AdultSolid Tumor, ChildhoodHematologic Cancer

Outcome Measures

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

    3 months following ACT

Secondary Outcomes (4)

  • Objective Response

    3 months following ACT

  • Progression-free survival

    5 years after first ACT infusion

  • Overall survival

    5 years after first ACT infusion

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

    From enrollment to 30 days after the last sample

Study Arms (1)

Patients receiving advanced therapy medicinal products

EXPERIMENTAL
Procedure: Tumor biopsyProcedure: Blood sampleProcedure: Bone marrow sample

Interventions

Tumor biopsyPROCEDURE

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

Patients receiving advanced therapy medicinal products
Blood samplePROCEDURE

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

Patients receiving advanced therapy medicinal products
Bone marrow samplePROCEDURE

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

Patients receiving advanced therapy medicinal products

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gustave Roussy Cancer Campus Grand Paris

Villejuif, Val De Marne, 94805, France

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Camille BIGENWALD, MD

CONTACT

+33 (0)1 42 11 42 29camille.bigenwald@gustaveroussy.fr

Cristina CASTILLA LLORENTE, MD

CONTACT

+33 (0)1 42 11 42 39cristina.castilla-llorente@gustaveroussy.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2022

First Posted

August 1, 2022

Study Start

June 8, 2022

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

June 24, 2025

Record last verified: 2025-06

Locations

FR(1)