Status:
UNKNOWN
Residual Disease Driven Strategy for CARCIK (CD19) in Adults/Pediatric BCP-ALL
Lead Sponsor:
Fondazione Matilde Tettamanti Menotti De Marchi Onlus
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
1-75 years
Phase:
PHASE2
Brief Summary
This is a single arm, open-label, multi-center, phase II study to determine the activity and the safety of a therapeutic strategy that allows a second CARCIK-CD19 cells infusion, driven by the status ...
Eligibility Criteria
Inclusion
- Children (1-17) and adults (18-75 years old);
- Relapsed or refractory adult and pediatric B- ALL as defined for the presence of bone marrow with ≥ 5% lymphoblasts by morphologic assessment, or if \<5%, with at least 1% of molecular disease at PCR;
- Evidence of CD19 tumor expression in bone marrow and/or peripheral blood by flow cytometry;
- Diagnosis of CD19 positive ALL in the bone marrow, and/or peripheral blood and/or extramedullary sites with the exclusion of Central Nervous System (CNS) if CNS-3 disease.
Exclusion
- GVHD Grades II-IV for patients who had previously been transplanted; 2. Any cell therapy in the previous 30 days;
- Patient with concomitant life-threatening infectious disease;
- Lansky/Karnofsky score \<60;
- Patients with hepatic or renal disease as specific above;
- Pregnant or breast-feeding females;
- Rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy;
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT05252403
Start Date
December 1 2021
End Date
March 1 2025
Last Update
May 6 2023
Active Locations (2)
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1
Ospedale PG23
Bergamo, Italy
2
Fondazione MBBM
Monza, Italy