This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD19 CARvac in patients with relapsed and/or refractory B cell malignancies.
CD19 CARvac is a chimeric antigen receptor immunotherapy treatment designed to treat
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
CD19 CARvac T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy.
The General Hospital of Western Theater Command
Chengdu, China
RECRUITINGPeking University Shenzhen Hospital
Shenzhen, China
RECRUITINGNumber of participants with dose limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: 28 days
Type of dose-limiting toxicity (DLT)
Time frame: 28 days
Number of participants with adverse event by severity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: 2 years
Overall Response Rate (ORR)
Assessment of morphologic complete remission (CR), complete remission with incomplete recovery of counts (CR1), no residual disease as analyzed by flow cytometry analysis, and molecular remission by molecular studies
Time frame: 1 year
Progression-free survival (PFS)
Time frame: 1 year
Overall survival
Time frame: 1 year
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