This is a study to evaluate the safety and clinical activity of ThisCART19 (Allogeneic CAR-T targeting CD19) in patients with refractory or relapsed CD19 positive B cell malignancies.
This is a single-center, nonrandomized, open-label study to evaluate the safety and clinical activity of ThisCART19 in patients with refractory or relapsed CD19 positive B cell malignancies, such as acute or chronic lymphocytic leukemia, lymphoma and etc. The dose range is 0.2-60 x 10\^6 cells per kg body weight.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
0.2-60 x 10\^6 CAR T cells per kg body weight.
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Hefei, Anhui, China
RECRUITINGFundamenta Therapeutice Co.,Ltd
Suzhou, Jiangsu, China
RECRUITINGIncidence of Dose Limiting Toxicities
To assess adverse events as dose limiting toxicities as defined by the protocol.
Time frame: From infusion to Day 28
Complete Remission
Proportion of patients in whom with morphologic complete remission (CR)
Time frame: At Day 28 after ThisCART19 infusion
TRM: Treatment Related Mortality
The mortality related with ThisCART19 infusion.
Time frame: Up to 2 years
Objective Response Rate
For Acute Lymphoblastic Leukemia (ALL), Objective response rate(ORR) is the percentage of patients who achieve CR or chronic lymphocytic leukemia(CRi); for chronic lymphocytic leukemia (CLL) and lymphoma, ORR is the incidence of either a complete response (CR) or a partial response (PR).
Time frame: Up to 1 year
Duration of Response
Duration of Response (DOR) defined as the duration (days) from initial response to disease relapse, progression, or death due to any course.
Time frame: Up to 1 year
Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Time frame: From inclusion up to 1 year
Overall Survival Rate of 2 Years
The rate of patients whom alive at year 2
Time frame: At year 2
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