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Trial Title: An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors

NCT ID: NCT05481502

Condition: Solid Tumor, Adult
Solid Tumor, Childhood
Hematologic Cancer

Conditions: Official terms:
Neoplasms
Hematologic Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Other

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Tumor biopsy
Description: 3 biopsies will be collected: at baseline, at day+15 and optionally at relapse
Arm group label: Patients receiving advanced therapy medicinal products

Intervention type: Procedure
Intervention name: Blood sample
Description: 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
Arm group label: Patients receiving advanced therapy medicinal products

Intervention type: Procedure
Intervention name: Bone marrow sample
Description: 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
Arm group label: Patients receiving advanced therapy medicinal products

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.

Criteria for 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.

Gender: All

Minimum age: 2 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Gustave Roussy Cancer Campus Grand Paris

Address:
City: Villejuif
Zip: 94805
Country: France

Status: Recruiting

Contact:
Last name: Camille BIGENWALD, MD

Phone: +33 (0)1 42 11 42 29
Email: camille.bigenwald@gustaveroussy.fr

Contact backup:
Last name: Clementine MAHAUT

Phone: +33 (0)1 42 11 23 34
Email: clementine.mahaut@gustaveroussy.fr

Start date: June 8, 2022

Completion date: July 1, 2026

Lead sponsor:
Agency: Gustave Roussy, Cancer Campus, Grand Paris
Agency class: Other

Source: Gustave Roussy, Cancer Campus, Grand Paris

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05481502

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