NCT03881761

CD19/20 Bispecific Nanobody-derived CAR-T Cells in B Cell Lymphoma

Clinical Study of CD19/CD20 Bispecific Nanobody-derived CAR-T Cells in Refractroy/Relasped B Cell Lymphoma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 17 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Evaluation the safety and efficacy of CD19/CD20 bispecific CAR-T cells in patients with relapsed/refractory B cell lymphoma

Detailed description

CART cell therapy has become the treatment of choice for patients with relapsed/ refractory B cell lymphoma. Currently, CAR-T cells approved for relapsed/refractory B-cell lymphoma are mainly CAR19-T cells. Nearly half of patients who relapse after treatment with CAR19-T cells are caused by tumor cell antigen escape. Dual-target CAR-T cells targeting CD19 and CD20 may reduce the recurrence rate after treatment. This study was to evaluate the efficacy and safety of CD19/CD20 bispecific CAR-T cells in patients with relapsed/refractory B cell lymphoma.

Conditions

• B-Cell Lymphoma Stage I
• Refractory
• Relapsed

Interventions

Type	Name	Description
BIOLOGICAL	CD19/CD20 bispecific CAR-T cells	collecting blood for CAR-T cells culture three days later, FC regimen (fludarabine 30mg/m2/d x 3, cyclophosphamide 600-800mg/m2/d x 2) another two days later, transfusing CD19/CD20 bispecific CAR-T cell with a dose of 1-3x106/kg

Timeline

• Start date: 2019-02-01
• Primary completion: 2021-01-31
• Completion: 2022-01-31
• First posted: 2019-03-19
• Last updated: 2019-03-21

Locations

2 sites across 1 country: China