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

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.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor, Adult; Solid Tumor, Childhood; Hematologic Cancer
• Intervention / Treatment: Procedure: Tumor biopsy; Procedure: Blood sample; Procedure: Bone marrow sample

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Camille BIGENWALD, Dr; Phone Number: +33(0)142114229; Email: camille.bigenwald@gustaveroussy.fr
• Study Contact Backup: Name: Cristina CASTILLA LLORENTE, Dr; Phone Number: +33(0)142114239; Email: cristina.castilla-llorente@gustaveroussy.fr

Study Locations

• France
  • Val De Marne
    • Villejuif, Val De Marne, France, 94805
      • Recruiting
      • Gustave Roussy Cancer Campus Grand Paris
      • Contact: Camille BIGENWALD, Dr; Phone Number: +33(0)142114229; Email: camille.bigenwald@gustaveroussy.fr
      • Contact: Clementine MAHAUT; Phone Number: +33(0)142112334; Email: clementine.mahaut@gustaveroussy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients receiving advanced therapy medicinal products

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Objective Response	Defined by RECIST 1.1 score for lymphoma and solid tumors	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.	5 years after first ACT infusion
Overall survival	Defined as the time between the adoptive cell therapy injection and death whatever the cause	5 years after first ACT infusion
Safety of biopsies procedures (when applicable) graded according to CTCAE v5.0		From enrollment to 30 days after the last sample

Collaborators and Investigators

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: June 24, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 29, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms
• Other Study ID Numbers: 2022-A00472-41; 2022/3404 (Other Identifier: CSET number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No