NCT03528421

Assessment of Safety and Efficacy of IM19 for Relapsed or Refractory NHL Patients

Clinical Study to Evaluate the Safety and Efficacy of IM19 CAR-T Cell Therapy in Patients With Relapsed or Refractory CD19-positive Non-Hodgkin's Lymphoma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

n this study, approximately 30 patients with relapsed or refractory non-Hodgkin's lymphoma (NHL) were recruited for a single reinfusion of IM19-CD28 and IM19-41BB CAR-T cells. Assess the safety, tolerability of treatment, and initially observe the efficacy.

Detailed description

1. Dose-escalation:Patients entered the IM19-41BB or IM19-CD28 group and performed dose escalation studies in three dose groups. 2. According to the results of the previous dose escalation study, select one dose to continue the enrollment of 6 patients for extended studies.

Conditions

• Non Hodgkin Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	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: 2018-05-22
• Primary completion: 2020-04-01
• Completion: 2020-05-01
• First posted: 2018-05-17
• Last updated: 2018-07-16

Locations

1 site across 1 country: China