NCT04546893

Safety and Efficacy Study of SL1904B CAR-T Cells for Relapsed or Refractory B-Cell Acute Lymphocyte Leukemia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Hebei Senlang Biotechnology Inc., Ltd. · Industry
• Sex: All
• Age: 2 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is an open, single-arm, clinical study to evaluate efficacy and safety of anti CD19 CAR-T cell in the treatment of recurrent or refractory B-ALL

Detailed description

The CARs consist of an anti-CD19 single-chain variable fragment（scFv） that was derived from the FMC63 mouse hybridoma, a portion of the human CD137（4-1BB） molecule, and the intracellular component of the human CD3ζ molecule. Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy. The Main research objectives: To evaluate the safety and efficacy of 1904B in patients with recurrent or refractory B-ALL The Secondary research objectives: To investigate the cytokinetic characteristics of 1904B in patients with recurrent or refractory B-ALL

Conditions

• B-ALL

Interventions

Type	Name	Description
BIOLOGICAL	CD19 CAR-T	Biological: CD19 CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis;

Timeline

• Start date: 2020-09-01
• Primary completion: 2022-09-01
• Completion: 2022-12-01
• First posted: 2020-09-14
• Last updated: 2020-09-14

Locations

2 sites across 1 country: China