NCT04237428

CD19-CART in the Treatment of R/R CD19 Positive Non-Hodgkin's Lymphoma

Clinical Study on the Treatment of Relapsed or Refractory CD19 Positive Non-Hodgkin's Lymphoma Patients With Target CD19 Chimeric Antigen Receptor T Cell Infusion

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of targeted CD19 chimeric antigen receptor T cell infusion in the treatment of relapsed or refractory CD19 positive non-Hodgkin's lymphoma.

Conditions

• Non Hodgkin Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	CD19 CAR-T cells infusion	Biological: CD19 CAR-T cells infusion Biological: CD19 CAR-T cells infusion. Pretreatment: patients enrolled in this study will receive cyclophosphamide or fludarabine plus cyclophosphamide. CD19 CAR-T cells infusion are allowed within 2 weeks after treatment. CD19 CAR-T cells infusion: 30-60 minutes before infusion, H1 anti-histamine agents are applied (acetaminophen 30mg,po.; promethazine 25mg,i.v. ; diphenhydramine 0.5-1mg/kg, no more than 50mg.). Non-physiological doses of corticosteroids are not applied for patients during treatment or recovery unless a life-threatening emergency occurs. CD19 CAR-T cells are infused into patients for one time, the number of infused CD19 CAR-T cells are 0.5-4×10\^6/kg.

Timeline

• Start date: 2019-05-31
• Primary completion: 2019-06-15
• Completion: 2021-05-31
• First posted: 2020-01-23
• Last updated: 2020-01-23

Locations

1 site across 1 country: China