Response to Chimeric Antigen Receptor (CAR)-T Cells Therapy in Patients With Hematologic Malignancies Depending on Tumor Characteristics

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age15+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

Immunotherapy with Chimeric Antigen Receptor (CAR) T Cells, T cells whose receptor has been genetically modified, is based on improving the immune response against the tumor. This approach is promising for patients with hematologic malignancies refractory to chemotherapy. Despite impressive results, too many patients are relapsing. The reasons for the relapse, after the injection of CAR T cells, need to be explored. In this context of newly introduced therapeutics, it is essential to better understand the factors associated with the response to treatment with CAR T Cells, especially the characteristics of the tumor and its microenvironment.

The objective of this study is to understand the role of tumor biology, and its microenvironment, in the response to CAR-T Cells therapy in patients with hematologic malignancies

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patient with hematological malignancy (lymphoma, ALL, MM)

patient integrated into a CAR-T Cells program treatment

patient aged 15 years or over

patient having signed a written consent; as well as his legal representative if <18 years old

Disqualifiers

patient with other hematological malignancies than lymphoma, LAL or MM

patient's weight <58 kg

patient treated with another treatment than CAR-T Cells

patient under tutorship or curatorship

Trial population

Patients with hematological malignancy

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

600 Participants
are grouped into 1 trial group
Group A: Patients with haematological malignancy

Trial outcomes

Primary outcomes

1

Complete response rate

Time frame
90 days after (CAR)-T cell therapy initiation

Secondary outcomes

1

Overall Survival rate

Time frame
1 year
2

Objective response rate

Time frame
30 days
3

Objective response rate

Time frame
90 days
4

Objective response rate

Time frame
1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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