NCT02935153

A Clinical Research of CD22-Targeted CAR-T in B Cell Malignancies

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Southwest Hospital, China · Academic / Other
• Sex: All
• Age: 14 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The overall purpose of this study is to explore the therapeutic effect of CD22-targeted chimeric antigen receptor T(CAR-T) cells in the treatment of Malignant B-cell Derived Leukemia and Lymphoma.

Detailed description

CD22 is a type I transmembrane protein expressed on most mature B lymphocyte in the B cell malignancies，and plays a significant role in signal transduction pathways．Despite of the fact that CD19-targeted CAR-T can re-induce remissions for many patients with relapsed and refractory B cell malignancies, a part of those patients will relapse with CD19-negative malignancies. To explore a rescue for those with CD19-negative B cell malignancies, we design and conduct this trial to test the safety and effectiveness of CD22-targeted CAR-T.

Conditions

• Leukemia
• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	Anti-CD22-CAR-transduced T cells	The first 3 enrolled patients will receive autologous-derived CD22-targeted CAR-T cells on day 1, 2 and 3 with respective 10%, 30% and 60% of the total expected dosage after receiving lymphodepleting chemotherapy. If the 3 patients don't display severe toxicity, the next patients enrolled will get infused in 2 days with respective 40% and 60% total dosage.

Timeline

• Start date: 2016-10-01
• Primary completion: 2019-10-01
• Completion: 2020-10-01
• First posted: 2016-10-17
• Last updated: 2019-06-25

Locations

1 site across 1 country: China