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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05481502
Other study ID # 2022-A00472-41
Secondary ID 2022/3404
Status Recruiting
Phase N/A
First received
Last updated
Start date June 8, 2022
Est. completion date July 1, 2026

Study information

Verified date September 2023
Source Gustave Roussy, Cancer Campus, Grand Paris
Contact Camille BIGENWALD, Dr
Phone +33(0)142114229
Email camille.bigenwald@gustaveroussy.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date July 1, 2026
Est. primary completion date July 1, 2026
Accepts healthy volunteers No
Gender All
Age group 2 Years and older
Eligibility 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.

Study Design


Intervention

Procedure:
Tumor biopsy
3 biopsies will be collected: at baseline, at day+15 and optionally at relapse
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
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

Locations

Country Name City State
France Gustave Roussy Cancer Campus Grand Paris Villejuif Val De Marne

Sponsors (1)

Lead Sponsor Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 3 months following ACT
Secondary Objective Response Defined by RECIST 1.1 score for lymphoma and solid tumors 3 months following ACT
Secondary Progression-free survival Defined as the time between the adoptive cell therapy and progression, or death whatever the cause, whichever occurs first. 5 years after first ACT infusion
Secondary Overall survival Defined as the time between the adoptive cell therapy injection and death whatever the cause 5 years after first ACT infusion
Secondary Safety of biopsies procedures (when applicable) graded according to CTCAE v5.0 From enrollment to 30 days after the last sample
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