Tissue Study in Patients Undergoing CAR-T Cell Therapy (CAR_21_01)

Condition(s) studied

Study summary

The "CAR-T" immunotherapy ("Chimeric Antigen Receptor T cell therapies") is a therapy based on T cells expressing a chemical receptor for a specific antigen indicated for patients with some types of oncohematological pathologies that have not responded to other forms treatment, such as: relapsed or refractory non-Hodgkin's lymphomas, including diffuse large B-cell lymphoma, primary B-cell mediastinal lymphoma, transformed follicular lymphoma, mantle cell lymphoma, acute lymphoblastic leukemia, in children and young adults (\<26 years) and multiple myeloma. This therapy is an absolutely innovative approach which consists of a personalized live cell immunotherapy that modifies the immune system of the recipient patient to make it able to recognize and eradicate the neoplastic cells expressing the antigen towards which the cells have been engineered.

This approach has several biological advantages:

1. to supply the patient with "reprogrammed T cells" with a new and specific activation mechanism;
2. overcoming immune tolerance towards cancer cells;
3. bypassing HLA-mediated antigen recognition restriction mechanisms;

Eligibility

Primary outcome measure(s)

• Study of epigenetics — 5 years
  Study of epigenetics in peripheral blood samples taken from patients undergoing CAR-T therapy. In particular, the epigenetic analysis will be performed in the circulating leukocyte and extracellular fraction contained in the plasma nanovesicles in order to determine the epigenome and its correlation with the clinical outcome.
• Study of microRNA — 5 years
  study of microRNAs extracted from extracellular vesicles and leukocytes of patients undergoing CAR-T therapy in order to correlate levels with clinical outcome.
• study of lymphocyte and myeloid populations — 5 years
  study of lymphocyte and myeloid populations in the haematological patient PRE and POST CAR-T cell infusion in order to correlate the levels with the clinical outcome.

Trial sites (1)

More IRCCS Azienda Ospedaliero-Universitaria di Bologna trials in Italy