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

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05481502
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 48.8
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor, Adult; Solid Tumor, Childhood; Hematologic Cancer	Procedure: Tumor biopsy; Procedure: Blood sample; Procedure: Bone marrow sample	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: Jun 8, 2022
• Anticipated Primary Completion Date: Jul 1, 2026
• Anticipated Study Completion Date: Jul 1, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Objective Response [3 months following ACT]

   Defined by RECIST 1.1 score for lymphoma and solid tumors

2. 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.

3. Overall survival [5 years after first ACT infusion]

   Defined as the time between the adoptive cell therapy injection and death whatever the cause

4. Safety of biopsies procedures (when applicable) graded according to CTCAE v5.0 [From enrollment to 30 days after the last sample]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gustave Roussy Cancer Campus Grand Paris	Villejuif	Val De Marne	France	94805

Sponsors and Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
• ClinicalTrials.gov Identifier: NCT05481502
• Other Study ID Numbers: 2022-A00472-41; 2022/3404
• First Posted: Aug 1, 2022
• Last Update Posted: Aug 1, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms; Hematologic Neoplasms

Study Results

No Results Posted as of Aug 1, 2022