NCT03312205

CAR-T Cells for Relapsed or Refractory Haematopoietic and Lymphoid Malignancies

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Hebei Senlang Biotechnology Inc., Ltd. · Industry
• Sex: All
• Age: 1 Year – 70 Years
• Healthy volunteers: Not accepted

Summary

This is an open, single-arm, phase I/phase II clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of hematopoietic and lymphoid malignancies. A total of 50 patients are planned to be enrolled over a period of 2 years.

Detailed description

Chimeric antigen receptor (CAR)-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. Besides CD19, many other molecules such as CD22, CD30,BCMA, CLL-1, etc. may be potential in developing the corresponding CAR-T cells to treat patients whose tumors expressing those markers. Investigators have developed a high efficient platform for constructing different CARs and preclinical studies have demonstrated effective killing of corresponding target cells. In this study, investigators will evaluate their safety and efficacy in patients with different types of hematopoietic and lymphoid malignancies. The primary goal is safety assessment including cytokine storm response and any other adverse effects. In addition, tumor targeting and disease status after treatment will also be evaluated.

Conditions

• Leukemia
• Lymphoma
• Multiple Myeloma of Bone (Diagnosis)

Interventions

Type	Name	Description
BIOLOGICAL	Autologous CAR-T cells	Patients will be drawn 50-100 ml blood to obtain enough peripheral blood mononuclear cells (PBMC) for CAR-T manufacturing. The T cells will be purified from the PBMC, transduced with CAR lentiviral vector, expanded in vitro and then frozen for future administration. Chemotherapy will then be given. Following tumor burden reassessment, CAR-T cells will be infused.

Timeline

• Start date: 2017-08-29
• Primary completion: 2019-08-29
• Completion: 2023-08-29
• First posted: 2017-10-17
• Last updated: 2019-01-09

Locations

1 site across 1 country: China