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

Gustave Roussy, Cancer Campus, Grand Paris160 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

160

Conditions

Solid Tumor, Adult Solid Tumor, Childhood Hematologic Cancer

Interventions

Tumor biopsyPROCEDURE

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

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

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

Eligibility

Sex: ALLMin age: 2 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Objective Response

Defined by RECIST 1.1 score for lymphoma and solid tumors

Time frame: 3 months following ACT

Progression-free survival

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

Time frame: 5 years after first ACT infusion

Overall survival

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

Time frame: 5 years after first ACT infusion

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

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