NCT04283006

A Study of CD20/CD22 Targeted CAR T-cell Therapy for Relapsed or Refractory Lymphoid Malignancies

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: He Huang · Academic / Other
• Sex: All
• Age: 3 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A Study of CD20/CD22 Targeted CAR T-cell Therapy for Relapsed or Refractory Lymphoid Malignancies.

Detailed description

Relapsed/refractory hematological malignancies has a short survival time and a high mortality rate. A number of clinical trials in China and at abroad have shown that CAR T-cells targeting CD19 have a high remission rate and limited adverse effects in the treatment of relapsed/refractory leukemia, which has great clinical application prospect. The New England Journal (NEJM) reported in 2010 and 2013 that the Carl June's team at the University of Pennsylvania used CAR T-cells against CD19 to treat B-cell malignancies successfully. On August 30, 2017, the US FDA first approved Novartis CAR T-cells for the treatment of acute lymphocytic leukemia. Our center has completed the treatment of 33 cases of acute lymphoblastic leukemia with CAR-T cells targeting CD19, with a complete remission rate of 90% and 10 cases of lymphoma treated with CAR T-cells. At present, the international clinical trials of CD20 / CD22 dual-target CAR T-cells in the treatment of relapsed/refractory lymphoid hematological malignancies have achieved impressive results, but the number of patients needs to be further verified. Based on the results of prior studies and the lack of effective treatment options for relapsed/refractory hematological malignancies, we have applied for a clinical trial of CD20 / CD22 dual-target CAR T-cells to treat relapsed/refractory hematological malignancy. This is a single arm, open-label, single-center study. Patients with CD20 and CD22-positive relapsed/refractory hematological malignancies have an estimated survival of 2 years. The purpose is to evaluate the safety and effectiveness of CD20 / CD22 dual-target CAR T-cell therapy through this clinical trial study, and to provide clinical basis and experience for CAR T-cell technology in the treatment of clinical malignant hematological diseases.

Conditions

• Relapsed and Refractory
• Lymphoid Hematological Malignancies

Interventions

Type	Name	Description
DRUG	CD20/CD22 dual Targeted CAR T-cells	Each subject receive CD20/CD22 dual Targeted CAR T-cells by intravenous infusion

Timeline

• Start date: 2018-05-23
• Primary completion: 2023-05-23
• Completion: 2028-05-23
• First posted: 2020-02-25
• Last updated: 2020-08-21

Locations

1 site across 1 country: China