Status:
COMPLETED
Transposon-manipulated Allogeneic CARCIK-CD19 Cells in Pediatric and Adult Patients With r/r ALL Post HSCT
Lead Sponsor:
Fondazione Matilde Tettamanti Menotti De Marchi Onlus
Conditions:
Acute Lymphoblastic Leukemia, in Relapse
Eligibility:
All Genders
1-75 years
Phase:
PHASE1
PHASE2
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 patien...
Eligibility Criteria
Inclusion
- 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
- Patients with GVHD Grades II-IV;
- Any cell therapy in the last 30 days;
Key Trial Info
Start Date :
December 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2022
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03389035
Start Date
December 20 2017
End Date
December 30 2022
Last Update
May 6 2023
Active Locations (2)
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1
Ospedale PG23
Bergamo, BG, Italy, 24127
2
Fondazione MBBM
Monza, MB, Italy, 20900