Acute B cell lymphoblastic leukemia
Conditions
Interventions
Experimental group:GC019F
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 70 years, male or female; 2.Eastern cooperative oncology group (ECOG) performance status of 0 to 2; 3.Life expectancy >= 12 weeks; 4.CD19 tumor expression demonstrated in bone marrow or peripheral blood by flow cytometry; 5.Diagnosed as B-cell acute lymphoblastic leukemia (B-ALL) by bone marrow examination and met one of the following conditions: (1) Refractory B- ALL: Fail to achieve CR after 2 cycles of a standard induction chemotherapy regimen or one-line/multi-line salvage chemotherapy; (2) Relapsed B- ALL: First relapse if first remission = 5% lymphoblasts by morphologic assessment; 7.Did not receive hematopoietic stem cell transplantation 60 mL/min; (2) Both serum ALT and AST = 0.1x10^9/L; (5) Echocardiography showed left ventricular ejection fraction (LVEF) > 50%, no evidence of clinically significant pericardial effusion; (6) No clinically significant pleural effusion; (7) Baseline oxygen saturation > 92% on room air. 9.Females of reproductive age must be in non-lactation period. Females of childbearing potential must have a negative serum or urine pregnancy test. All subjects must use medical-approved-contraception (such as intrauterine device and contraceptive drugs) during the treatment and in 2 years after cell transfusion treatment; Males should avoid sperm donation; 10.Venous access can be established, peripheral blood mononuclear cells (PBMC) can be collected in investigator's judgement; 11.The subject agrees to and sign informed consent form; 12.The subject can communicate well with the investigator, is willing and able to comply with the research plans, and finish the research according to the research rule.
Exclusion criteria
Exclusion criteria: 1.Isolated extramedullary leukemia or isolated extramedullary disease relapse; 2.Central nervous system leukemia involved CNS3; 3.Concomitant malignancy other than cured non-melanoma skin cancer or cervical carcinoma in situ or localized prostate cancer or superficial bladder cancer or ductal carcinoma in situ or diagnosis of other malignancy exceeds 5 years without relapse or treatment during the 5 years; 4.Any result of the following infectious disease tests is positive: HIV; HCV; HBsAg; or HBcAb positive with HBV DNA copies positive; TPPA; 5.Live vaccine = grade 2 acute graft-versus-host disease (GVHD, Glucksberg criteria) or extensive chronic GVHD (Seattle criteria) that require treatment = grade III), severe arrhythmia that require drug treatment, underwent cardiac angioplasty/coronary stent implantation/ cardiac bypass surgery <=6 months prior to enrollment; 17.Presence of central nervous system (CNS) disease or medical history, including epilepsy, cerebral ischemia/bleeding, dementia, cerebellar disease, or any autoimmune disease that involves CNS; 18.Uncontrollable active infection (e.g. sepsis, bacteremia, fungemia, viremia) at screening; 19.In investigator's judgement, due to any other condition, it is inappropriate for the subject to anticipate the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| dose-limiting toxicity;laboratory examination;vital signs;physical examination;replication competent lentivirus;lentiviral gene insertion and integration sites examination;levels of B cells and T cells in peripheral blood and bone marrow; | — |
Secondary
| Measure | Time frame |
|---|---|
| CAR copies in peripheral blood;CAR copies in bone marrow;CAR copies in cerebrospinal fluid;GC019F cells in peripheral blood;GC019F cells in bone marrow;GC019F cells in cerebrospinal fluid;CAR-T / T cells in peripheral blood;overall response rate;CAR-T cell immunophenotype in bone marrow;CAR-T cell immunophenotype in peripheral blood;cytokines in cerebrospinal fluid;cytokines in peripheral blood;anti-GC019F antibody in peripheral blood;progression-free survival;overall survival;duration of response;The proportion of patients achieved complete remission and MRD negative; | — |
Countries
China
Contacts
Public ContactZhang yI
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed