A Prospective Trial to Evaluate Immune Determinants of the Response and the Toxicity to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Patients receiving advanced therapy medicinal products
Intervention: Tumor biopsy (Procedure)
Patients receiving advanced therapy medicinal products
Intervention: Blood sample (Procedure)
Patients receiving advanced therapy medicinal products
Intervention: Bone marrow sample (Procedure)
Outcomes
Primary Outcomes
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 Outcomes
- Progression-free survival(5 years after first ACT infusion)
- Objective Response(3 months following ACT)
- Overall survival(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)