Actively Recruiting
A Prospective Trial to Evaluate Immune Determinants of the Response and the Toxicity to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Led by Gustave Roussy, Cancer Campus, Grand Paris · Updated on 2025-06-24
160
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the immune changes in tumors, blood, and bone marrow following the infusion of somatic cell therapy drugs in patients with solid tumors or hematologic cancers. The study aims to identify specific phenotypic, transcriptional, and epigenetic profiles of immune cells within tumors and correlate these profiles with clinical responses and potential toxicities. This research is designed to explore how different cellular components respond to adoptive cell therapy over time. Participants will undergo several procedures including three tumor biopsies taken at baseline, day 15, and optionally at relapse. Blood samples will be collected seven times at key intervals before and after treatment, including at day -7, day 0, day 3, day 7, day 15, month 3, and at relapse. If bone marrow biopsies or aspirations are done as part of routine care, additional samples will be taken for analysis. During the study, researchers will monitor immune cell changes using spectral flow cytometry and RNA sequencing three months after therapy infusion. They will also evaluate objective response at three months, and track progression-free and overall survival over five years. Safety of biopsy procedures will be assessed from enrollment until 30 days after the last sample. Participants are expected to comply with protocol requirements and provide informed consent, with total participation varying based on individual treatment and follow-up.
CONDITIONS
Brief Title
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 older than 2 years can be included
- No restriction about the Eastern Cooperative Oncology Group (ECOG) status
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - At least 3 months following ACT infusion
Participants undergo adoptive cell therapy (ACT) and have tumor biopsies and blood samples collected to evaluate immune response and treatment effects.
Multiple visits including baseline, day 0, day 3, day 7, day 15, and month 3 for blood samples and tumor biopsies
Duration - Up to 5 years after first ACT infusion
Participants are observed for progression-free and overall survival for up to 5 years following the first ACT infusion.
Visits as per routine follow-up care
Trial Site Locations
Total: 1 location
1
Gustave Roussy Cancer Campus Grand Paris
Villejuif, Val De Marne, France, 94805
Actively Recruiting
Research Team
C
Camille BIGENWALD, MD
C
Cristina CASTILLA LLORENTE, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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