This is an open, single-arm, prospective, dose-escalation clinical trial designed to evaluate the safety and the preliminary efficacy of CD19-targeted CAR-T combined with CAR-DC in the treatment of relapsed and refractory B-cell lymphoma
6-18 patients are planned to be enrolled in the dose-escalation trial. The dose of CD19-CAR-DC was according to the 3+3 dose-escalation principle (0.25×10\^6/kg, 0.5×10\^6/kg, 0.75×10\^6/kg ( ±20%) . CAR-T was 2×10\^6/kg . The primary endpoints are DLT, MTD, and the second endpionts are the overall response rates (CR and PR), overall survival, and progression-free survival. Based on the results in the dose-escalation trial, the recommended dose will be determined. Another 52 patients will be enrolled to continue estimating the safety and efficacy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Intravenously injected CAR DC cells and followed by CAR T cells 4 hours later
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hanzhou, Zhejiang, China
RECRUITINGDLT
To evaluate the safety, tolerability, and determine the recommended dosage of combined therapy of CD19 CAR-T and CD19 CAR-DC for Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Time frame: Up to 28 days
MTD
MTD was the highest dose for DLT in ≤1/6 subjects
Time frame: Up to 28 days
Incidence of abnormalities
Incidence of abnormalities in AE/SAE/AESI/laboratory tests/electrocardiograms/vital signs.
Time frame: Up to 28 days
Overall Response Rate
The proportion of CR or PR patients as assessed by investigators based on Lugano 2014 Response Assessment
Time frame: Up to 2 years
Duration of Response
The time from the start of the first assessment of CR or PR to the first assessment as disease recurrence or progression or death
Time frame: Up to 2 years
Progression Free Survival
The length of time that a participant's disease did not progress during or after CAR-T treatment.
Time frame: Up to 2 years
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