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

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Trial to Evaluate Immune Determinants of the Response and the Toxicity to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors

Conditions
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Solid Tumor, Adult, Solid Tumor, Childhood, Hematologic Cancer

Intervention / Treatment
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* Procedure: Tumor biopsy
* Procedure: Blood sample
* Procedure: Bone marrow sample


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients receiving advanced therapy medicinal products<br> | Procedure: Tumor biopsy<br>* 3 biopsies will be collected: at baseline, at day+15 and optionally at relapse<br>Procedure: Blood sample<br>* 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<br>Procedure: Bone marrow sample<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response | Defined by RECIST 1.1 score for lymphoma and solid tumors | 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. | 5 years after first ACT infusion | 
| Overall survival | Defined as the time between the adoptive cell therapy injection and death whatever the cause | 5 years after first ACT infusion | 
| Safety of biopsies procedures (when applicable) graded according to CTCAE v5.0 |  | From enrollment to 30 days after the last sample |