Hematologic Cancer, Solid Tumor, Adult, Solid Tumor, Childhood
Conditions
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.
Interventions
PROCEDURETumor biopsy
3 biopsies will be collected: at baseline, at day+15 and optionally at relapse
PROCEDUREBlood 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
PROCEDUREBone 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
Gustave Roussy, Cancer Campus, Grand Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Objective Response | 3 months following ACT | Defined by RECIST 1.1 score for lymphoma and solid tumors |
| Progression-free survival | 5 years after first ACT infusion | Defined as the time between the adoptive cell therapy and progression, or death whatever the cause, whichever occurs first. |
| Overall survival | 5 years after first ACT infusion | 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 | From enrollment to 30 days after the last sample | — |
Countries
France
Contacts
Primary ContactCamille BIGENWALD, MD
Backup ContactCristina CASTILLA LLORENTE, MD
Outcome results
None listed