NCT04440436

Assessment of Safety and Efficacy of IM19 for Recurrent or Refractory (R/R) Non-Hodgkin's Lymphoma(NHL) Patients

Phase I/II Clinical Study to Evaluate the Safety and Efficacy of IM19 Chimeric Antigen Receptor T Cells(CAR-T) in the Treatment of Recurrent or Refractory (R/R) CD19 Positive Aggressive Non-Hodgkin's Lymphoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I/II, multicenter study to assess the efficacy and safety of IM19 CAR-T cells in adult with R/R Non-Hodgkins Lymphoma in China.

Detailed description

This is a phase Ⅰ/Ⅱ. The phase I is a single-center study. The main objective is to evaluate the safety of IM19 CAR-T cell therapy for patients with relapsed or refractory CD19-positive invasion of non-Hodgkin's lymphoma. The phase Ⅱ is a multi-center study,The main goal is to evaluate the efficacy of IM19 CAR-T cells in the treatment of patients with relapsed or refractory CD19-positive invasion of non-Hodgkin's lymphoma.

Conditions

• NHL

Interventions

Type	Name	Description
DRUG	IM19 CAR-T Cells	IM19 CAR-T cells Drug: Fludarabine Two days before cell infusion, all patients will be treated with fludarabine for 3 days Drug: Cyclophosphamide Two days before cell infusion, all patients will be treated with Cyclophosphamide for 3 days

Timeline

• Start date: 2020-06-04
• Primary completion: 2022-06-04
• Completion: 2035-06-04
• First posted: 2020-06-19
• Last updated: 2020-12-08

Locations

1 site across 1 country: China