About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Tumor biopsy
Procedure/Surgery3 biopsies will be collected: at baseline, at day+15 and optionally at relapse
Blood sample
Procedure/Surgery7 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/SurgeryIf 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
Treatment groups
Trial 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
Secondary outcomes
Objective Response
Defined by RECIST 1.1 score for lymphoma and solid tumors
Progression-free survival
Defined as the time between the adoptive cell therapy and progression, or death whatever the cause, whichever occurs first.
Overall survival
Defined as the time between the adoptive cell therapy injection and death whatever the cause
Safety of biopsies procedures (when applicable) graded according to CTCAE v5.0
Sponsors and contacts
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