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Trial Title:
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
NCT ID:
NCT05481502
Condition:
Solid Tumor, Adult
Solid Tumor, Childhood
Hematologic Cancer
Conditions: Official terms:
Neoplasms
Hematologic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Tumor biopsy
Description:
3 biopsies will be collected: at baseline, at day+15 and optionally at relapse
Arm group label:
Patients receiving advanced therapy medicinal products
Intervention type:
Procedure
Intervention name:
Blood sample
Description:
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
Arm group label:
Patients receiving advanced therapy medicinal products
Intervention type:
Procedure
Intervention name:
Bone marrow sample
Description:
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
Arm group label:
Patients receiving advanced therapy medicinal products
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
2 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Gustave Roussy Cancer Campus Grand Paris
Address:
City:
Villejuif
Zip:
94805
Country:
France
Status:
Recruiting
Contact:
Last name:
Camille BIGENWALD, MD
Phone:
+33 (0)1 42 11 42 29
Email:
camille.bigenwald@gustaveroussy.fr
Contact backup:
Last name:
Clementine MAHAUT
Phone:
+33 (0)1 42 11 23 34
Email:
clementine.mahaut@gustaveroussy.fr
Start date:
June 8, 2022
Completion date:
July 1, 2026
Lead sponsor:
Agency:
Gustave Roussy, Cancer Campus, Grand Paris
Agency class:
Other
Source:
Gustave Roussy, Cancer Campus, Grand Paris
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05481502