Bio-CAR-T BS Study

NCT05366569 | Recruiting

• 1 other identifier: BIO-CAR-T BS 2022
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Evaluation of change post-infusion CAR-T cell expansion and persistence in patients with DLBCL, PMBCL and ALL undergoing CAR-T therapy evaluated by flow-cytometry and measures by number of cells/mL

  At day +1; +3; +7; +10; +14; +21; +30; +60; +90; +120; +150; +180; +210; +240; +270; +300; +330; +360 post CAR-T cell infusion or at any time for relapse/CRS-ICANS onset (assessed up to 2 years))

• Change of disease burden after CAR-T Cells treatment

  Disease response will be evaluated according to Lugano criteria

  At day +30; +90; +180; 270 and + 360 post CAR-T infusion

Secondary Outcomes (3)

• Number of participants with treatment-related adverse events as assessed by CTCAE v 4.0 and ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells

  At day +1; +3; +7; +10; +14; +21; +30; +60; +90; +120; +150; +180; +210; +240; +270; +300; +330; +360 post CAR-T cell infusion or at any time for relapse/CRS-ICANS onset (assessed up to 2 years)

• Evaluation of disease persistence and immune recovery and neurological biomarkers after CAR-T infusion

  Before starting the treatment and at day +1; +3; +7; and +30 after infusion of CAR-T cell and in case of development of neurological symptoms

• Evaluation of plasma level of biomarkers for ICANS neural damage and glial activation in patients who develop ICANS.

  Before starting the treatment and at day +1; +3; +7; and +30 after infusion of CAR-T cell and in case of development of neurological symptoms

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Calculation is based on the primary endpoints, i.e. the persistence of the CAR-T cells and the percentage of patients infused. As the Investigator have no formal statistical hypothesis to test, sample size justification is based on estimating the 95% confidence interval for the above percentage. Based on the UOC Hematology and Pediatric Oncohematology's experience and accrual potential, the Investigators are expecting about 180 patients newly diagnosed with DLBCL or PMBCL or ALL (potential candidate to CAR-T therapy) in a 3-year time window. About 25% of these patients are expected to be eligible to CAR T-cell treatment, corresponding to 45 patients. Thus, assuming a 25% percentage of patients infused, a sample size of 45 patients will produce a two-sided 95% confidence interval ranging from 12% to 38%, with a precision (half-width of 95% confidence interval) equal to 13%.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: lead

Study Sites (1)

ASST Spedali Civili di Brescia

Brescia, 25123, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 36358694 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood collection follow routinely timepoints for CAR-T Cell treatment monitoring. Therefore, the study is considered observational and not interventional.

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Lymphoid; Leukemia; Hematologic Diseases

Central Study Contacts

Domenico Russo, MD

CONTACT

00390303996811; domenico.russo@unibs.it

Mirko Farina, MD

CONTACT

00390303996811; m.farina004@unibs.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Clinical Unit; Clinical Professor;

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: May 9, 2022
• Study Start: April 26, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 30, 2026

Record last verified: 2025-10

Locations

IT (1)