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

NCT05481502 · tracked via the Priya Life Science France tracker

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Phase

Not applicable

Started

2022-06-08

Last updated

2025-06-24

Condition(s) studied

Solid Tumor, AdultSolid Tumor, ChildhoodHematologic Cancer

Investigational drug(s) / intervention(s)

Tumor biopsyBlood sampleBone marrow sample

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

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

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

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.

Eligibility

Sex

ALL

Min age

2 Years

Max age

—

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.

Primary outcome measure(s)

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

Trial sites (1)

Facility	City	Region	Status
Gustave Roussy Cancer Campus Grand Paris	Villejuif	Val De Marne	Recruiting

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Other trials for the same condition

First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or Advanced Breast Cancer Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05481502 on ClinicalTrials.gov ↗ ← All trials in France