This investigator-initiated, prospective, single-arm, open-label, single-center clinical study aims to evaluate the efficacy and safety of Inaticabtagene autoleucel (Inati-cel;CNCT19)CD19 CAR-T theraphy in adults B-ALL that are in first complete remission(CR1) with minimal residual disease (MRD) positivity. This trial will enroll 20 participants for leukapheresis and treatment with lymphodepleting chemotherapy followed by Inati-cel CAR T cell infusion. Patients will be assessed for MRD negativity rate(at months 1, 2, 3, and 6 after CAR-T transfusion), duration of MRD negativity, overall survival(OS), relapse-free survival(RFS), pharmacokinetics(PK) characteristics, incidence of adverse events(AEs), exploratory biomarker research at 1,2,3,6,9,12,15,18,21 and 24- months post Inati-cel infusion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Inaticabtagene autoleucel will be transfusioned intravenously at the recommended dose of 0.5×10\^8 (ranging 0.2-0.6×10\^8) viable CAR-T cells. If the quantity of CAR-T cells of the patient is sufficient, after the patient receives the first CAR-T transfusion 5\~6 months,they will receive a second CAR-T cell transfusion. The aim of the second transfusion is to prolong the duration of CAR-T in the patient's body and prolong the patient's DOR. The dose and procedures of the second transfusion are the same as those for the first transfusion. After the second infusion, the patient will receive evaluation based on the day of the second transfusion as Day0.
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGMRD negativity rate
The proportion of patients who reach MRD negative.Bone marrow of every patient will be analysed by multiparameter flow cytometry or/and RT-qPCR for MRD evaluation.
Time frame: up to 24 months
Duration of MRD negativity
Time from the first assessment of MRD negative to the first assessment of MRD positive or death from any cause.Bone marrow of every patient will be analysed by multiparameter flow cytometry or/and RT-qPCR for MRD evaluation.
Time frame: till the end of the study, up to 5 years
Relapse-free survival (RFS)
Interval from the date of transfusion of the Inati-cel to the time of hematological recurrence or death from any cause. Evaluation of RFS will be based on follow-up results.
Time frame: till the end of the study, up to 5 years
Overall survival (OS)
Interval from the date of the feedback to the time of death due to any reason. Evaluation of OS will be based on follow-up results.
Time frame: till the end of the study, up to 5 years
incidence of adverse events
The proportion of patients who have adverse events after Inati-cel transfusion.Adverse events will be assessed by CTCAE v5.0
Time frame: up to 24 months
Pharmacokinetics characteristics of Inati-cel
Including duration of CAR T cells, relative proportion of CAR-T cells and absolute counts of CAR-T cells.These will be evaluated by multiparameter flow cytometry.
Time frame: till the end of the study, up to 5 years
exploratory biomarker research
A small amount of blood or bone marrow will be collected for further biomarker research, including flowcytometric analysis of lymphocyte subsets, multiomics analysis of leukenic cells and CAR-T cells, in vivo and in vitro experiments on drug interference in CAR-T therapy.
Time frame: till the end of the study, up to 5 years
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