This is a dose-escalation, single-arm, single-center open study which aims to evaluate the maximum tolerated dose (MTD) and dose-dependent toxicity (DLT) of a novel oncolytic vaccinia virus expressing bispecific antibody RGV004 in patients with relapsed/refractory B-cell lymphoma,
Oncolytic vaccinia virus administered by intratumoral injection
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
a genetically-engineered vaccinia virus (encoding CD19/CD3 bispecific antibody)
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGTo define the Max tolerated dose (MTD) of RGV004
According to the principle of '3+3' dose escalation, if one patient experiences a Dose limiting Toxicity (DLT), up to three additional patients will be treated at the same dose level. If DLT is observed in only one of six patients treated at a given dose level, the next cohort of three patients will be treated at the next higher dose level. If two or more patients experience DLT at a particular dose level, then the dose escalation will cease and any subsequent patients will be treated at a lower dose level. Thus finding the Max tolerated dose (MTD)
Time frame: Up to 28 days
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
To evaluate the number of Grade III and above side effects assessed by CTCAE v5.0 for patients who received intratumoral administration of RGV004 injection in patients with R/R B-cell lymphoma.
Time frame: Up to 2 years
Objective remission rate (ORR)
The percentage of participants who achieved complete remission (CR) and partial remission (PR) over all participants
Time frame: Up to 2 years
RGV004 viral DNA in blood
Viral DNA load will be summarized by cohort
Time frame: Up to 2 years
RGV004 viral shedding in saliva
Viral DNA will be analyzed by qPCR
Time frame: Up to 2 years
RGV004 viral shedding in urine
Viral DNA will be analyzed by qPCR
Time frame: Up to 2 years
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