Phase 1-2a Trial to Determine the Feasibility and Safety of a Single Dose of Transposon-manipulated Allogeneic CARCIK-CD19 Cells in Adult and Pediatric Patients With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia, After Hematopoietic Stem Cell Transplantation

Fondazione Matilde Tettamanti Menotti De Marchi Onlus2 sites in 1 country21 target enrollmentDecember 20, 2017

ConditionsAcute Lymphoblastic Leukemia, in Relapse

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Acute Lymphoblastic Leukemia, in Relapse
Sponsor: Fondazione Matilde Tettamanti Menotti De Marchi Onlus
Enrollment: 21
Locations: 2
Primary Endpoint: Dose Limiting Toxicities (DLT):
Status: Completed
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 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.

Registry

clinicaltrials.gov

Start Date

December 20, 2017

End Date

December 30, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

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-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;