Therapeutic strategy driven by residual disease for CARCIK-CD19 in patients with relapsed/refractory B cell precursor Acute Lymphoblastic Leukemia
Key facts
- Where
- Bergamo és Monza, OlaszországSee the 2 sites
- Phase
- 2. fázis
Where in Olaszország
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIBergamo, OlaszországNo longer taking part
- Fondazione IRCCS San Gerardo dei TintoriMonza, OlaszországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fondazione Tettamanti
- Trial code
- EU 2024-519394-19-00
- Record updated
- 2025. július 31.
- Original description
To confirm the high overall response rate at day 28 after the first CARCIK-CD19 infusion and to improve the duration of response of patients treated with CARCIK -CD19 cells.Read full original descriptionShow less
Measurable residual disease driven strategy for one or two infusions of nonviral, transposon-manipulated CARCIK CD19 cells. A Phase II study in pediatric and adult patients with relapsed/refractory B cell precursor ALL (BCP-ALL).
To confirm the high overall response rate at day 28 after the first CARCIK-CD19 infusion and to improve the duration of response of patients treated with CARCIK -CD19 cells.
Inclusion: Children (1-17) and adults (18-75 years old); Absence of severe renal disease (creatinine > x 3 normal for age); Absence of severe hepatic disease (direct bilirubin > 3 mg/dl or SGOT > 500); Patient/guardian able to give informed consent; Relapsed or refractory adult and pediatric BCP-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; Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening, or if <5%, with at least 1% of molecular disease at PCR; No evidence of overall aGVHD > Grade I or chronic GVHD (cGVHD) greater than mild at time of enrollment and in the previous 30 days; No longer taking immunosuppressive agents for at least 30 days prior to infusion; No evidence of concomitant life-threatening infectious disease; Life expectancy > 60 days; Lansky/Karnofsky scores > 60.
Exclusion: GVHD Grades II-IV for patients who had previously been transplanted; Any cell therapy in the last 30 days; Patient with concomitant life-threatening infectious disease; Subjects must have recovered from the acute side effects of their prior therapy, such that eligibility criteria are met; Uncontrolled, symptomatic, intercurrent illness including but not limited to infection, congestive heart failure, unstable angina pectoris and cardiac arrhythmia; Active Central Nervous System (CNS) involvement by malignancy, defined as CNS-3 per National Comprehensive Cancer Network (NCCN) guidelines. Note: Patients with history of CNS disease that has been effectively treated will be eligible; Patients with hepatic or renal disease as specific above; Rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy; HIV/HBV/HCV Infection: Seropositive for HIV antibody. Seropositive for hepatitis C or positive for Hepatitis B surface antigen (HBsAG); Lansky/Karnofsky score <60; Pregnant or breast feeding females.