A Phase 1 interventional study of IM19 and Fludarabine in Non Hodgkin Lymphoma, sponsored by Beijing Immunochina Medical Science & Technology Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-16.
Sponsored by Beijing Immunochina Medical Science & Technology Co., Ltd. · Phase 1, Interventional, and Treatment
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 30 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma 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:
3\*10\^5/kg,1\*10\^6/kg,3\*10\^6/kg IM19 CAR-T cell.Two days before cell infusion, all patients will be treated with fludarabine and Cyclophosphamide for 3 days
Biological: IM19 · Drug: Fludarabine · Drug: Cyclophosphamide
CAR-T cells
Two days before cell infusion, all patients will be treated with fludarabine for 3 days
Two days before cell infusion, all patients will be treated with Cyclophosphamide for 3 days
Occurrence of study related adverse events
\>= Grade 3 signs/symptoms,laboratory toxicities,and clinical events that are possibly,likely,or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria 2.
Time frame: 2 years
Overall response rate
(1) a morphologic complete response (CR) or (2) a complete response with incomplete recovery of counts (CRi) (based on NCCN guidelines (National Comprehensive Cancer Network (NCCN), 2014)
Time frame: 2 years
Plan to share: No
This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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Beijing Immunochina Medical Science & Technology Co., Ltd.