A Phase 1/2 interventional study of IM19 CAR-T Cells in NHL, sponsored by Beijing Immunochina Medical Science & Technology Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-08.
Sponsored by Beijing Immunochina Medical Science & Technology Co., Ltd. · Phase 1/2, Interventional, and Treatment
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.
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.
1,989 studies on the registry are indexed under Lymphoma, Non-Hodgkin; 307 are open to participants now.
This study's planned enrollment of 52 is above the median of 41 across 1,703 interventional studies indexed under Lymphoma, Non-Hodgkin.
Browse Lymphoma, Non-Hodgkin studies →Beijing Immunochina Medical Science & Technology Co., Ltd. is the lead sponsor of 26 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
IM19 CAR-T cells be administrated in two dose level
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
Also known as: Fludarabine, Cyclophosphamide
Objective Response Rate(ORR) at 90 days
The primary endpoint was ORR 90 days after IM19 infusion
Time frame: 90 days
Plan to share: No
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Beijing Immunochina Medical Science & Technology Co., Ltd.