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

Solid Tumor, Adult Clinical Trial

— PIONEER  

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

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
• 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
• 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.

Related Conditions & MeSH terms

• Hematologic Cancer
• Hematologic Neoplasms
• Neoplasms
• Solid Tumor, Adult
• Solid Tumor, Childhood

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