NCT05807789: CAR_22

Molecular-genetic Characterization in Patients Undergoing CAR-T Cell Infusion

Recruiting now Last updated 27 December 2024

What this trial tests

trial in Hematologic Malignancy in 150 participants. Currently enrolling.

Timeline

23 February 2023

Primary endpoint
31 May 2026

31 May 2027

Quick facts

Lead sponsor	IRCCS Azienda Ospedaliero-Universitaria di Bologna
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	150
Start date	23 February 2023
Primary completion	31 May 2026
Estimated completion	31 May 2027
Sites	1 location across Italy

Conditions studied

• Hematologic Malignancy — all drugs for Hematologic Malignancy →

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna — full company profile →

Who can join

Adults 18 to 70, any sex, with Hematologic Malignancy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In recent years, the application of increasingly advanced methods of ex-vivo cell culture and cell engineering has made it possible to develop new cellular therapeutic platforms including the "CAR (Chimeric Antigen Receptor) - T cell therapy". CAR-T cell therapy is a therapy that uses T lymphocytes engineered to express a chimeric receptor directed against a specific antigen, theoretically applicable to the treatment of all neoplasms but currently more widely used in the treatment of haematological malignancies. One of the most innovative aspects introduced with CAR-T cell therapy is that of living-drug, cells that act as a drug as well as a means to build specific immunity against the neoplasm. The advantages of this therapy are therefore represented by the possibility of refueling the patient's immunity, deficient in the control of the neoplastic disease, with lymphocytes capable of expressing an antineoplastic activity with mechanisms not subject to restriction of HLA-mediated antigen recognition.

However, the use of CAR-T therapies is not free from potentially serious and sometimes lethal adverse events; in the toxicity profile the following are recognizable as peculiar:

* cytokine release syndrome (CRS)
* B-cell aplasia (hypogammaglobulinemia)
* neurological adverse reactions
* haematological toxicity
* infections. Therefore, considering that on the one hand adverse events are not negligible and on the other hand that a percentage \> 50% of patients lose the response obtained, it is necessary to improve the therapeutic profile of CAR-T cell therapy by increasing its efficacy and reducing its toxicity . Both of these strategies are linked to the understanding of the resistance mechanisms of neoplastic cells, as well as to the biology of CAR-T cells and of all the cellular (microenvironment) and non-cellular systems with which they interact.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. CAR+ extracellular vesicles predict ICANS in patients with B cell lymphomas treated with CD19-directed CAR T cells.
   Storci G, De Felice F, Ricci F, Santi S, et al · · 2024 · cited 23× · PMID 38833312 · DOI 10.1172/jci173096
2. Single-cell RNA sequencing: enhancing the predictive accuracy of tumor immunotherapy efficacy.
   Zhou W, Huang Z, Wu Z, Tang M, et al · · 2025 · cited 3× · PMID 40857744 · DOI 10.1042/ebc20253017
3. Detection of Brain-Derived Cell-Free DNA in Plasma.
   Pellegrini C, Ravaioli F, De Fanti S, Pirazzini C, et al · · 2024 · cited 1× · PMID 39594207 · DOI 10.3390/diagnostics14222541