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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGOccurrence 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
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