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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2+
SponsorGustave Roussy, Cancer Campus, Grand Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Tumor biopsy

    Procedure/Surgery

    3 biopsies will be collected: at baseline, at day+15 and optionally at relapse

  • Blood sample

    Procedure/Surgery

    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

    Procedure/Surgery

    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

Treatment groups

160 Participants
are divided into 1 treatment group
Group A: Patients receiving advanced therapy medicinal productsExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

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

Time frame
3 months following ACT

Secondary outcomes

1

Objective Response

Defined by RECIST 1.1 score for lymphoma and solid tumors

Time frame
3 months following ACT
2

Progression-free survival

Defined as the time between the adoptive cell therapy and progression, or death whatever the cause, whichever occurs first.

Time frame
5 years after first ACT infusion
3

Overall survival

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

Time frame
5 years after first ACT infusion
4

Safety of biopsies procedures (when applicable) graded according to CTCAE v5.0

Time frame
From enrollment to 30 days after the last sample

Other outcomes

Sponsors and contacts

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