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

Not Applicable

Recruiting

• Conditions: Hematologic Cancer; Solid Tumor, Childhood; Solid Tumor, Adult
• Interventions: Procedure: Tumor biopsy; Procedure: Blood sample; Procedure: Bone marrow sample

• Registration Number: NCT05481502
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-08
• Study First Submitted: 2022-06-24
• Study First Submitted QC: 2022-07-28
• Study First Posted: 2022-08-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-14
• Primary Completion: 2026-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients receiving advanced therapy medicinal products	Tumor biopsy	-
Patients receiving advanced therapy medicinal products	Bone marrow sample	-
Patients receiving advanced therapy medicinal products	Blood sample	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Gustave Roussy Cancer Campus Grand Paris; 🇫🇷 Villejuif, Val De Marne, France