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

NCT05481502 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-06-24

No results posted yet for this study

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.

Conditions

  • Solid Tumor, Adult
  • Solid Tumor, Childhood
  • Hematologic Cancer

Interventions

PROCEDURE

Tumor biopsy

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

PROCEDURE

Blood sample

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

PROCEDURE

Bone marrow sample

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

Sponsors & Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-08
Primary Completion
2027-07-01
Completion
2027-07-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05481502 on ClinicalTrials.gov