Evaluation of CAR-T cell therapy in certain blood cancers
Bio-CAR-T Study on Pre and Post-infusion CAR-T Cell Therapy
This study is testing how well CAR-T cell therapy works and lasts in patients with certain types of blood cancers, while also looking for signs that could predict how they respond to treatment and any side effects they might have.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Academic / other |
| Drugs / interventions | CAR-T, Chimeric Antigen Receptor, CAR T |
| Locations | 1 site (Brescia) |
| Trial ID | NCT05366569 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the expansion and persistence of CAR-T cells in patients with Diffuse Large B Cell Lymphoma (DLBCL), Primary Mediastinal Large B-cell Lymphoma (PMBCL), and Acute Lymphoblastic Leukemia (ALL) after CAR-T therapy. It includes several biological sub-studies that analyze CAR-T cell dynamics, circulating extracellular vesicles, and neurological markers associated with complications like ICANS. The study employs advanced techniques such as Flow Cytometry and digital PCR for monitoring CAR-T cell subsets and aims to identify biomarkers that could predict treatment responses and complications.
Who should consider this trial
Good fit: Ideal candidates include patients aged 18-70 with relapsed/refractory DLBCL or PMBCL, and patients aged 25 or younger with B-cell-ALL.
Not a fit: Patients outside the specified age range or with significant co-morbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of CAR-T therapy effectiveness and improve patient outcomes through better monitoring and management of treatment responses.
How similar studies have performed: While CAR-T therapy has been extensively studied, this specific observational approach focusing on post-infusion dynamics and biomarkers is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Brescia
- ASST Spedali Civili di Brescia — Brescia, Italy (Recruiting)
Study contacts
- Study coordinator: Domenico Russo, MD
- Email: domenico.russo@unibs.it
- Phone: 00390303996811
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.