This study is a single arm, open label, dose exploring clinical trial to evaluate the safety, efficacy, cellular metabolic dynamics, and pharmacodynamics of ct1190b cells in relapsed / refractory B-cell acute lymphoblastic leukemia.
voluntarily participate in clinical research; I fully understand and know this study and sign the informed consent form; ;
aged 12-75 years (inclusive);
The patients who did not achieve complete remission by the standardized induction chemotherapy, or early relapse (<12 months) after complete remission, or late relapse (≥ 12 months) after complete remission, and did not achieve complete remission by the standardized one course induction chemotherapy (except for the patients with late relapse who did not have a better treatment or did not tolerate other treatments according to the investigator's assessment), relapsed after 2 or more CR or CRI;
For ph+all patients, in addition to receiving standard induction chemotherapy, they should also receive at least two kinds of TKI treatment without complete remission or relapse after complete remission (except those who cannot tolerate TKI treatment or have contraindications to TKI treatment, or those with T315I mutation do not need to receive TKI treatment);
pregnant or lactating women;
there is HIV, syphilis infection, active hepatitis B virus infection (HBV-DNA is higher than the detection limit), or active hepatitis C virus infection (both HCV antibody and HCV-RNA are positive);
there is currently any uncontrollable active infection, including but not limited to patients with active tuberculosis (judged by the investigator);
there is active systemic autoimmune disease;
Single group
CT1190B cell injection
Biological/VaccineThe active ingredient of the drug in this study is the chimeric antigen receptor targeting cd19/cd20 (car-cd19/cd20 for short) modified allogeneic T cells. In order to reduce the rejection of GVHD and host immune cells, TCR and B2M were knocked out, and the related modifications were also carried out to reduce the host NK cell immune rejection.
The number and severity of dose-limiting toxicity (DLT)events
DLT was collected to explore the maximum tolerated dose (MTD) and / or dose range of CT1190B
Frequency, type and severity of AES
The frequency, type and severity of adverse events (AES) were collected. All adverse events will be evaluated according to the common terminology criteria for adverse events (CTCAE, version 5.0).
Investigator assessed objective response rate (ORR)
Investigator assessed complete response rate (CRR)
Investigator assessed proportion of minimal residual disease negative (MRD)
Investigator assessed duration of remission (DOR)
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