Bio-CAR-T BS Study

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT05366569

BIO-CAR-T BS 2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.