Acute Lymphoblastic Leukemia, in Relapse
Conditions
Keywords
Acute Lymphoblastic Leukemia, CAR-T, CARCIK, Transposon
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.
Interventions
BIOLOGICALCARCIK-CD19
Allogeneic (donor-derived) Cytokine Induced Killer (CIK) cells transduced with a transposon CD19 Chimeric Antigen Receptor (CAR) gene
Sponsors
Fondazione Matilde Tettamanti Menotti De Marchi Onlus
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 75 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Limiting Toxicities (DLT): | 1 month | rate and severity of the cytokine release syndrome (CRS) |
Countries
Italy
Outcome results
None listed