An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tumor biopsy, Blood sample, Bone marrow sample.
- Who it may be relevant to
- Registry conditions: Solid Tumor, Adult, Solid Tumor, Childhood, Hematologic Cancer. Basic parameters: from 2 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Procedure Tumor biopsy
3 biopsies will be collected: at baseline, at day+15 and optionally at relapse - Procedure 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 - Procedure 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
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 [Time frame: 3 months following ACT]
Secondary outcome measures (4)
- Objective Response [Time frame: 3 months following ACT]
- Progression-free survival [Time frame: 5 years after first ACT infusion]
- Overall survival [Time frame: 5 years after first ACT infusion]
- Safety of biopsies procedures (when applicable) graded according to CTCAE v5.0 [Time frame: From enrollment to 30 days after the last sample]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Gustave Roussy Cancer Campus Grand Paris — Villejuif
Identifiers
NCT: NCT05481502 · 2022-A00472-41 · 2022/3404