NCT03574168

CD19-CAR-T Cells in Patients With R/R B-ALL

Phase I Study of the Safety and Efficacy of CD19-CAR-T Cells in Patients With Relapsed or Refractory Acute B-cell Lymphoblastic Leukemia (R/R B-ALL)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Bioceltech Therapeutics, Ltd. · Industry
• Sex: All
• Age: 3 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of autologous or donor-derived allogeneic T cells expressing CD19 chimeric antigen receptors (referred to as "CD19-CAR-T cells") in patients with relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL).

Detailed description

Primary objective: To investigate the safety and efficacy of autologous or HLA-haploidentical Allo-CD19-CAR-T cells in the treatment of patients with relapsed or refractory acute B-cell lymphoblastic leukemia. Secondary objective: To Assess the patient's quality of life after receiving the treatment.

Conditions

• B-cell Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	CD19-CAR-T Cells	T cells purified from the PBMC of subjects or subjects' relatives which depends on their conditions, transduced with 4-1BB/CD3-ζ lentiviral vector, expanded in vitro for future administration.

Timeline

• Start date: 2018-07-20
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2018-06-29
• Last updated: 2018-06-29

Locations

1 site across 1 country: China