Transposon-manipulated Allogeneic CARCIK-CD19 Cells in Pediatric and Adult Patients With r/r ALL Post HSCT
Phase 1
Completed
- Conditions
- Acute Lymphoblastic Leukemia, in Relapse
- Interventions
- Biological: CARCIK-CD19
- Registration Number
- NCT03389035
- Lead Sponsor
- Fondazione Matilde Tettamanti Menotti De Marchi Onlus
- Brief Summary
This is a single arm, open-label, multi-center, phase 1-2a study to determine the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose and the safety of CARCIK-CD19 in adult and pediatric patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
Inclusion Criteria
- Children (1-17) and adults (18-75 years old);
- Relapsed or refractory adult and pediatric B-cell precursor ALL after HSCT;
- 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;
- 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 enrollment;
Exclusion Criteria
- Patients with GVHD Grades II-IV;
- Any cell therapy in the last 30 days;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description CARCIK-CD19 CARCIK-CD19 -
- Primary Outcome Measures
Name Time Method Dose Limiting Toxicities (DLT): 1 month rate and severity of the cytokine release syndrome (CRS)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Ospedale PG23
🇮🇹Bergamo, BG, Italy
Fondazione MBBM
🇮🇹Monza, MB, Italy