NCT04943016

CD19 CAR T Cells in Children and Adults With Relapsed or Refractory CD19 Positive B Cell Malignancies

Phase I Clinical Trial of CD19 Chimeric Antigen Receptor (CAR) T Cells in Children and Adults With Relapsed or Refractory CD19 Positive B Cell Malignancies

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 1 Year – 65 Years
• Healthy volunteers: Not accepted

Summary

This study seeks to examine the feasibility and safety of the administration of autologous T cells that have been modified through the introduction of a chimeric antigen receptor targeting the B cell surface antigen CD19 following administration of chemotherapy lymphodepletion regimen in children and adults with relapsed/refractory B cell malignancies.

Detailed description

The overall goal of this study is to validate the safety profile of administration CD19 CAR T cells and describe the toxicities in children and adults with relapsed/ refractory B cell malignancies. The dose is escalated in standard 3 +3 design with a starting dose of 1x106 cell/kilogram and maximum treatment dose of 5 x 106 cell/kilogram. The minimum number of 9 subjects would occur if no dose-limiting toxicities are observed in the 3 dose escalation cohorts. The maximum sample size of 18 subjects would be enrolled in 3 dose escalation cohorts (six in each cohort) for meeting dose-limiting toxicities request. In addition, we hypothesize that we will be able to successfully manufacture CAR T cells to meet the established release criteria at a minimum target dose of 1 X 106 +-30% cells/kilogram in this patient population using the Miltenyi CliniMACS Prodigy® closed transduction system.

Conditions

• Relapsed/Refractory B-Cell Malignancies

Interventions

Type	Name	Description
DRUG	CD19 Chimeric Antigen Receptor (CAR) T Cells	This study seeks to examine the feasibility and safety of the administration of autologous T cells that have been modified through the introduction of a chimeric antigen receptor targeting the B cell surface antigen CD19 following administration of chemotherapy lymphodepletion regimen in children and adults with relapsed/refractory B cell malignancies. The overall goal of this study is to validate the safety profile of administration CD19 CAR T cells and describe the toxicities in children and adults with relapsed/ refractory B cell malignancies. Each patient implements leukapheresis 2 weeks after enrollment and infuse CD19 CAR-T cell around 2 weeks after leukapheresis, and administrated chemotherapy lymphodepletion regimen 1 week before infusion. Furthermore, the treated subject would be following up around 2 years.

Timeline

• Start date: 2021-07-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2021-06-29
• Last updated: 2021-06-29