RecruitingNCT05366569
Bio-CAR-T BS Study
Bio-CAR-T Study on Pre and Post-infusion CAR-T Cell Therapy
Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Enrollment
45 participants
Start Date
Apr 26, 2022
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Min Age: 18 YearsMax Age: 70 Years
Inclusion Criteria7
- 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 Criteria8
- 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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05366569
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