NCT04011293

A Clinical Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Injection (CNCT19) in the Treatment of Cluster of Differentiation 19 (CD19) Positive Relapsed or Refractory B Cell Malignancies

A Clinical Study of CNCT19 Cells in the Treatment of CD19 Positive Relapsed or Refractory B Cell Malignancies

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm, open-label, single center study to determine the safety and efficacy of CNCT19 in adult patients with Relapsed or Refractory B cell Malignancies.

Detailed description

This is a single arm, open-label, single-center study to determine the safety and efficacy of CNCT19 in adult patients with r/r B cell Malignancies. The study will have the following sequential phases: Screening, Pre-Treatment (Cell Product Preparation \& Lymphodepleting Chemotherapy), Treatment and Follow-up, and Survival Follow-up. The total duration of the study is 2 years from CNCT19 cell infusion.

Conditions

• Relapsed or Refractory Hematological Malignancies

Interventions

Type	Name	Description
BIOLOGICAL	CNCT19	0.5 to 4 x 10\^6 autologous CNCT19 transduced cells per kg body weight, with a maximum dose of 4 x 10\^8 autologous CNCT19 transduced cells via intravenous infusion.

Timeline

• Start date: 2019-07-01
• Primary completion: 2020-07-01
• Completion: 2022-04-01
• First posted: 2019-07-08
• Last updated: 2019-07-08

Locations

1 site across 1 country: China