Timely Leukapheresis May Interfere with the "Fitness" of Lymphocytes Collected for CAR-T Treatment in High Risk DLBCL Patients.
Mirko Farina, Marco Chiarini, Camillo Almici...
https://pubmed.ncbi.nlm.nih.gov/36358694Actively Recruiting
Age: 18Years - 70Years
All Genders
ID05366569
Bio-CAR-T Study on Pre and Post-infusion CAR-T Cell Therapy for Lymphoma and Leukemia
Led by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Updated on 2026-04-30
45
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with Diffuse Large B Cell Lymphoma (DLBCL), Primary Mediastinal Large B-cell Lymphoma (PMBCL), and Acute Lymphoblastic Leukemia (ALL) who have undergone CAR-T cell therapy. The study aims to evaluate the expansion and persistence of CAR-T cells after infusion and to explore the treatment's feasibility and effectiveness in real-life settings. It also includes biological sub-studies focused on monitoring CAR-T cells, analyzing extracellular vesicles, and assessing neurological markers related to immune cell-related neurotoxicity. The study involves detailed analyses using flow cytometry and digital PCR to track CAR-T cells over time. Blood and cerebrospinal fluid samples will be collected to quantify extracellular vesicles and examine their composition, aiming to identify markers that may predict patient responses or complications. Neurological biomarkers will be evaluated before and after CAR-T infusion to understand neurotoxicity development. These assessments are done at multiple time points up to two years after CAR-T cell infusion. Participants will be closely monitored through blood tests and clinical evaluations at scheduled intervals, including days 1, 3, 7, 10, 14, 21, 30, and several later time points up to one year and beyond. Researchers will measure CAR-T cell levels, disease burden, immune recovery, and neurological biomarkers. Safety will be assessed by tracking treatment-related side effects and neurotoxicity. The study lasts up to two years, allowing for long-term observation of outcomes and complications following CAR-T therapy.
CONDITIONS
Brief Title
Bio-CAR-T BS Study
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients with B-cell Acute Lymphoblastic Leukemia (ALL) aged 25 years or younger
- Patients with Diffuse Large B Cell Lymphoma (DLBCL) aged 18 to 70 years
- Patients with Primary Mediastinal Large B-cell Lymphoma (PMBCL) aged 18 to 70 years
- Relapsed or refractory after two lines of treatment
- 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 such as certain 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 will not qualify if you...
- Patients with B-cell Acute Lymphoblastic Leukemia (ALL) older than 25 years
- Patients with Diffuse Large B Cell Lymphoma (DLBCL) younger than 18 or older than 70 years
- Patients with Primary Mediastinal Large B-cell Lymphoma (PMBCL) younger than 18 or older than 70 years
- Performance status greater than 1
- Active or uncontrolled infections
- Thrombo-embolisms within the last 6 months
- Presence of clinically relevant co-morbidities such as certain cardiovascular, neurologic, or immune disorders with organ dysfunction or requiring immunosuppressive treatment in the last 24 months
- Life expectancy less than 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Monitoring
Duration - Up to 2 years post CAR-T cell infusion
Participants are monitored before and after CAR-T cell infusion to evaluate CAR-T cell expansion, persistence, and disease burden as well as to assess neurological and immune biomarkers.
Multiple visits at day +1, +3, +7, +10, +14, +21, +30, +60, +90, +120, +150, +180, +210, +240, +270, +300, +330, and +360 post infusion
Trial Site Locations
Total: 1 location
1
ASST Spedali Civili di Brescia
Brescia, Italy, 25123
Actively Recruiting
Loading map...
Research Team
D
Domenico Russo, MD
M
Mirko Farina, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here