Back to resultsAn Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors (PIONEER)
Primary Purpose
Solid Tumor, Adult, Solid Tumor, Childhood, Hematologic Cancer
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Tumor biopsy
Blood sample
Bone marrow sample
Sponsored by
About this trial
This is an interventional other trial for Solid Tumor, Adult
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.
Sites / Locations
- Gustave Roussy Cancer Campus Grand ParisRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients receiving advanced therapy medicinal products
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Objective Response
Defined by RECIST 1.1 score for lymphoma and solid tumors
Progression-free survival
Defined as the time between the adoptive cell therapy and progression, or death whatever the cause, whichever occurs first.
Overall survival
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
Full Information
NCT ID
NCT05481502
First Posted
June 24, 2022
Last Updated
September 29, 2023
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
1. Study Identification
Unique Protocol Identification Number
NCT05481502
Brief Title
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Acronym
PIONEER
Official Title
A Prospective Trial to Evaluate Immune Determinants of the Response and the Toxicity to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 8, 2022 (Actual)
Primary Completion Date
July 1, 2026 (Anticipated)
Study Completion Date
July 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor, Adult, Solid Tumor, Childhood, Hematologic Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients receiving advanced therapy medicinal products
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Tumor biopsy
Intervention Description
3 biopsies will be collected: at baseline, at day+15 and optionally at relapse
Intervention Type
Procedure
Intervention Name(s)
Blood sample
Intervention 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
Intervention Type
Procedure
Intervention Name(s)
Bone marrow sample
Intervention 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
Primary Outcome Measure Information:
Title
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
Time Frame
3 months following ACT
Secondary Outcome Measure Information:
Title
Objective Response
Description
Defined by RECIST 1.1 score for lymphoma and solid tumors
Time Frame
3 months following ACT
Title
Progression-free survival
Description
Defined as the time between the adoptive cell therapy and progression, or death whatever the cause, whichever occurs first.
Time Frame
5 years after first ACT infusion
Title
Overall survival
Description
Defined as the time between the adoptive cell therapy injection and death whatever the cause
Time Frame
5 years after first ACT infusion
Title
Safety of biopsies procedures (when applicable) graded according to CTCAE v5.0
Time Frame
From enrollment to 30 days after the last sample
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Camille BIGENWALD, Dr
Phone
+33(0)142114229
Email
camille.bigenwald@gustaveroussy.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Cristina CASTILLA LLORENTE, Dr
Phone
+33(0)142114239
Email
cristina.castilla-llorente@gustaveroussy.fr
Facility Information:
Facility Name
Gustave Roussy Cancer Campus Grand Paris
City
Villejuif
State/Province
Val De Marne
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camille BIGENWALD, Dr
Phone
+33(0)142114229
Email
camille.bigenwald@gustaveroussy.fr
First Name & Middle Initial & Last Name & Degree
Clementine MAHAUT
Phone
+33(0)142112334
Email
clementine.mahaut@gustaveroussy.fr
12. IPD Sharing Statement
Learn more about this trial
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
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