An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
NCT ID: NCT05481502
Last Updated: 2025-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
160 participants
INTERVENTIONAL
2022-06-08
2027-07-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Patients receiving advanced therapy medicinal products
Tumor biopsy
3 biopsies will be collected: at baseline, at day+15 and optionally at relapse
Blood 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
Bone 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
Interventions
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Tumor biopsy
3 biopsies will be collected: at baseline, at day+15 and optionally at relapse
Blood 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
Bone 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
Eligibility Criteria
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Inclusion Criteria
* 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
* Tumor lesion not accessible to core biopsies.
* Pregnant or nursing women cannot participate in this study.
2 Years
ALL
No
Sponsors
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Gustave Roussy, Cancer Campus, Grand Paris
OTHER
Responsible Party
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Locations
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Gustave Roussy Cancer Campus Grand Paris
Villejuif, Val De Marne, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022/3404
Identifier Type: OTHER
Identifier Source: secondary_id
2022-A00472-41
Identifier Type: -
Identifier Source: org_study_id
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