Residual Disease Driven Strategy for CARCIK (CD19) in Adults/Pediatric BCP-ALL

Fondazione Matilde Tettamanti Menotti De Marchi Onlus

Status and phase

Enrolling

Phase 2

Conditions

Acute Lymphoblastic Leukemia

Treatments

Genetic: PTG-CARCIK-CD19

Study type

Interventional

Funder types

Other

Identifiers

NCT05252403

FT03CARCIK

Details and patient eligibility

About

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 of disease from one month after the first infusion, in adult and pediatric patients with r/r BCP- ALL.

Enrollment

35 estimated patients

Sex

All

Ages

1 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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;