Bio-CAR-T BS Study

Recruiting now

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

In brief

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.

Key facts

Study ID

NCT05366569

Run by

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

People needed

45

Starts

2022-04-26

Expected to finish

2026-12-31

Last updated by the study team

2026-04-30

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• ASST Spedali Civili di Brescia — Brescia, Italy (enrolling)

Full record on ClinicalTrials.gov

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