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| ID | Type | Description | Link |
|---|---|---|---|
| 2022/3404 | Other Identifier | CSET number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients receiving advanced therapy medicinal products | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tumor biopsy | Procedure | 3 biopsies will be collected: at baseline, at day+15 and optionally at relapse |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Camille BIGENWALD, MD | Contact | +33 (0)1 42 11 42 29 | camille.bigenwald@gustaveroussy.fr | |
| Cristina CASTILLA LLORENTE, MD | Contact | +33 (0)1 42 11 42 39 | cristina.castilla-llorente@gustaveroussy.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gustave Roussy Cancer Campus Grand Paris | Recruiting | Villejuif | Val De Marne | 94805 | France |
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| Blood sample | Procedure | 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 |
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| Bone marrow sample | Procedure | 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 |
|
| 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 |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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