Measurable Residual Disease Driven Strategy for One or Two Infusions of Non- Viral, Transposon-manipulated CARCIK (CD19) Cells: A Phase II Study in Pediatric and Adult Patients With Relapsed/Refractory B Cell Precursor ALL (BCP-ALL)

Fondazione Matilde Tettamanti Menotti De Marchi Onlus2 sites in 1 country35 target enrollmentDecember 1, 2021

ConditionsAcute Lymphoblastic Leukemia

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Acute Lymphoblastic Leukemia
Sponsor: Fondazione Matilde Tettamanti Menotti De Marchi Onlus
Enrollment: 35
Locations: 2
Primary Endpoint: To evaluate the overall response rate: change from baseline at day 28 after the first CARCIK-CD19 infusion
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 1, 2021

End Date

March 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Fondazione Matilde Tettamanti Menotti De Marchi Onlus

Responsible Party

Sponsor

Eligibility Criteria

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;
•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;