Solid Tumor, AdultPIONEERNCT05481502
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
A study testing Tumor biopsy, Blood sample and Bone marrow sample in people with Solid Tumor, Adult and Solid Tumor, Childhood, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Solid Tumor, Adult, Solid Tumor, Childhood, Hematologic Cancer
- What is being tested?
- Tumor biopsy, Blood sample and Bone marrow sample
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jun 2022to 1 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cristina CASTILLA LLORENTE, MD contact
France1 site, 1 recruiting
- Recruiting
Gustave Roussy Cancer Campus Grand Paris
Villejuif, Val De Marne, 94805
Camille BIGENWALD, MD, +33 (0)1 42 11 42 29, camille.bigenwald@gustaveroussy.fr
Clementine MAHAUT, +33 (0)1 42 11 23 34, clementine.mahaut@gustaveroussy.fr
About this study
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
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.
- Being tested
- Tumor biopsy, Blood sample, Bone marrow sample
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor biopsyProcedure or surgery
3 biopsies will be collected: at baseline, at day+15 and optionally at relapse
Blood sampleProcedure or surgery
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
Bone marrow sampleProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving advanced therapy medicinal products | Experimental | Not described Receives: Procedure: Tumor biopsy; Procedure: Blood sample; Procedure: Bone marrow sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months following ACT
Secondary outcomes (4)
Objective Response
Defined by RECIST 1.1 score for lymphoma and solid tumors
Measured: 3 months following ACT
Progression-free survival
Defined as the time between the adoptive cell therapy and progression, or death whatever the cause, whichever occurs first.
Measured: 5 years after first ACT infusion
Overall survival
Defined as the time between the adoptive cell therapy injection and death whatever the cause
Measured: 5 years after first ACT infusion
Safety of biopsies procedures (when applicable) graded according to CTCAE v5.0
Measured: From enrollment to 30 days after the last sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start8 Jun 2022
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481502
- Sponsor's protocol ID
- 2022-A00472-41
- Other IDs
- 2022/3404
- Acronym
- PIONEER
- Status last verified
- Jun 2025
- First submitted
- 24 Jun 2022
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No