NCT03299738

A Study Evaluating Safety and Efficacy of C-CAR011 in Subjects With B-NHL

A Phase 1 Study Evaluating Safety and Efficacy of C-CAR011 in Subjects With B-cell Non-Hodgkin Lymphoma (NHL)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Shanghai AbelZeta Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm, single-center, non-randomized study to evaluate the safety and efficacy of C-CAR011 in relapsed or refractory B cell Non-Hodgkin Lymphoma (NHL).

Detailed description

The study will include the following sequential phases: Screening, Pre-Treatment (Cell Product Preparation, Lymphodepleting Chemotherapy), Treatment and Follow-up.

Conditions

• Refractory or Relapsed B-cell Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	C-CAR011	Autologous 2nd generation CD19-directed CAR-T cells, single infusion intravenously at a target dose of 0.5-5.0 x 10\^6 anti-CD19 CAR+ T cells/kg

Timeline

• Start date: 2017-12-01
• Primary completion: 2018-12-01
• Completion: 2019-08-01
• First posted: 2017-10-03
• Last updated: 2017-12-19

Locations

1 site across 1 country: China