Bio-CAR-T BS Study

NCT ID: NCT05366569

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-26
• Study Completion Date: 2026-04-30

Brief Summary

The aim of this Study is the evaluation of post-infusion CAR-T (Chimeric Antigen Receptor T Cell) expansion and persistence in patients with DLBCL, PMBCL and ALL undergoing CAR-T therapy; and the feasibility and efficacy of the treatment in the real life practice.

Detailed Description

This Study is characterized by several biological sub-studies, reported as below:

• Post-infusion CAR-T expansion and persistence analysis by both Flow Cytometry and digital PCR (dPCR): the aim of this point are the evaluation and enumeration of CAR T cells (CD4+ and/or CD8+) during patients follow-up and set up of specific panels for longitudinal evaluation and monitoring of CAR-T subsets.
• Circulating Extracellular Vesicles quantification and analysis on peripheral blood and CNS (Central Nervous System) liquor: the aim are the identification of alterations in small EVs (Extracellular vesicles) ( number and cargos composition (proteins or miRNA) after CAR-T cell infusion and identification of small EVs markers which may distinguish patients "good responders" from patients "not responders" and/or which may predict particular post-infusion complications.
• Evaluation of neurological markers for ICANS (Immune effector cell-associated neurotoxicity syndrome): the purpose of this substudy are the assessment of previously identified plasma and CSF (Cerebrospinal fluid)biomarkers for inflammation, neuronal damage and glial activation in patients who develop ICANS and the characterize temporal neuronal and glial involvement by assessing plasma and CSF inflammatory, neuronal and glial biomarkers in ICANS and their role on outcome.

Conditions

Diffuse Large B Cell Lymphoma (DLBCL); Primary Mediastinal Large B-cell Lymphoma (PMBCL); Acute Lymphoblastic Leukemia (ALL)

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patients with B-cell-ALL (≤ 25 years) or patients with DLBCL (18-70 years) or patients with PMBCL (18-70 years) who were relapsed/refractory after two lines of treatments;
• Adequate performance status (0 or 1);
• Adequate organ function;
• No active or uncontrolled infections;
• No thrombo-embolisms within the last 6 months;
• Absence of clinically relevant co-morbidities (e.g., select cardiovascular, neurologic, or immune disorders with organ dysfunction or requiring immunosuppressive treatment in the last 24 months);
• Life expectancy of at least 3 months.

Exclusion Criteria

• Patients with B-cell-ALL > 25 years
• Patients with DLBCL <18 or >70 years
• Patients with PMBCL <18 or >70 years
• Performance status > 1;
• Active or uncontrolled infections;
• Thrombo-embolisms within the last 6 months;
• Presence of clinically relevant co-morbidities (e.g., select cardiovascular, neurologic, or immune disorders with organ dysfunction or requiring immunosuppressive treatment in the last 24 months);
• Life expectancy < 3 months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

OTHER

Sponsor Role: lead

Responsible Party

Prof Domenico Russo

Head of Clinical Unit; Clinical Professor;

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

ASST Spedali Civili di Brescia

Brescia, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Domenico Russo, MD

Role: CONTACT

domenico.russo@unibs.it

00390303996811

Mirko Farina, MD

Role: CONTACT

m.farina004@unibs.it

00390303996811

Facility Contacts

Domenico Russo, MD

Role: primary

domenico.russo@unibs.it

00390303996811

Mirko Farina, MD

Role: backup

m.farina004@unibs.it

00390303996811

References

Farina M, Chiarini M, Almici C, Accorsi Buttini E, Zuccala F, Piva S, Volonghi I, Poli L, Bernardi S, Colnaghi F, Re F, Leoni A, Polverelli N, Turra A, Morello E, Galvagni A, Moratto D, Brugnoni D, Cattaneo C, Ferrari E, Bianchetti A, Malagola M, Re A, Russo D. Timely Leukapheresis May Interfere with the "Fitness" of Lymphocytes Collected for CAR-T Treatment in High Risk DLBCL Patients. Cancers (Basel). 2022 Oct 27;14(21):5276. doi: 10.3390/cancers14215276.

Reference Type: DERIVED

PMID: 36358694 (View on PubMed)

Other Identifiers

BIO-CAR-T BS 2022

Identifier Type: -

Identifier Source: org_study_id