CAR-LAM: AML Cell Immunotherapy Using Chimeric Antigen Receptor T-cells

Sponsor

Centre Hospitalier Universitaire de Besancon (Other)

Overall Status

Recruiting

CT.gov ID

NCT04169022

Collaborator

Centre Hospitalier Universitaire Dijon (Other), Etablissement Français du Sang (Other)

Enrollment

Location

Arms

46.7

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

AML is one of the most aggressive forms of leukemia, where bone marrow transplantation remains the gold standard treatment, with its known associated toxicities and related mortality. Despite progress in the treatment of leukemic malignancies, especially the emergence of targeted- and immuno-therapies arising from biological genomic knowledge, there remains a need to provide additional strategies for refractory/relapsing (R/R) patients

Aim of this study is to collect biological samples of AML patients in order to validate our Chimeric Antigen Receptor T-cells immunotherapy approach

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia	Other: Sample collection	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Targeting Interleukin 1 Receptor Accessory Protein (IL1RAP) Expressing Acute Myeloid Leukemic (AML) Cells by Chimeric Antigen Receptor (CAR) Engineered T-cells

Actual Study Start Date :

Jul 10, 2019

Anticipated Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AML patients at diagnosis AML patients at diagnosis (except AML3)	Other: Sample collection Sample collection blood and/or bone marrow
Experimental: AML patients at relapse AML patients at relapse after chemotherapy, targeted therapy or allograft	Other: Sample collection Sample collection blood and/or bone marrow

Arm

Intervention/Treatment

Experimental: AML patients at diagnosis

AML patients at diagnosis (except AML3)

Other: Sample collection

Sample collection blood and/or bone marrow

Experimental: AML patients at relapse

AML patients at relapse after chemotherapy, targeted therapy or allograft

Other: Sample collection

Sample collection blood and/or bone marrow

Outcome Measures

Primary Outcome Measures

IL1RAP protein expression [2 years]
Cytometry analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

AML patients adults and pediatrics

Exclusion Criteria:

AML3

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Besançon	Besançon		France	25000

Sponsors and Collaborators

Centre Hospitalier Universitaire de Besancon
Centre Hospitalier Universitaire Dijon
Etablissement Français du Sang

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Besancon

ClinicalTrials.gov Identifier:

NCT04169022

Other Study ID Numbers:

P/2018/402

First Posted:

Nov 19, 2019

Last Update Posted:

Feb 1, 2021

Last Verified:

Dec 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire de Besancon

AML

Chimeric Antigen Receptor T Cells

Immunotherapy

Study Results

No Results Posted as of Feb 1, 2021