Hematological malignancy
Conditions
Interventions
Case series:N/A
Sponsors
The First Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
13 Years to 69 Years
Inclusion criteria
Inclusion criteria: 1. Inclusion criteria for all only: (1) According to the National Comprehensive Cancer Network (NCCN) clinical practice guide for acute lymphoblastic leukemia (V1, 2016), patients were diagnosed with CD19 positive B-ALL by histology; (2) Diagnosed with r/r CD19+ B-ALL and confirmed with any of the following items: 1) CR was not obtained after standard chemotherapy; 2) CR was induced for the first time, but the duration of CR was less than 12 months; 3) The first or more salvage treatment was ineffective r/r CD19+ B-ALL; 4) Recurrence twice or more times; (3) The number of primary cells (primary and young) in bone marrow was more than 5% (morphology) and/or> 0.01% (flow cytometry); (4) Subjects with Philadelphia chromosome-negative (ph-); Or subjects who were not resistant to TKI or Philadelphia chromosome-positive (ph+) who did not respond to two TKI treatments; 2. Inclusion criteria for NHL only: (1) According to WHO classification standard of 2016 edition, the histology confirmed the diagnosis including DLBCL (NOS); Subjects with follicular lymphoma, DLBCL transformed by chronic lymphoblastic leukemia/small lymphomas, PMBCL, and advanced B-cell lymphoma were studied; (2) R/R B-NHL (met one of the following conditions): 1)The subjects did not alleviate or recur after receiving chemotherapy plan of second or above; 2)Primary drug resistance; 3)The subjects relapsed after receiving the transplantation of the stem cells; (3) According to Lugano 2014, there should be at least one tumor focus to be evaluated; 3. Only applicable to MM inclusion criteria: (1) Subjects with relapsed refractory multiple myeloma who met the following conditions: 1)BCMA was positive with relapse, refractory, and drug resistance. 2)After transplantation, DLI was ineffective. Donor cells in the recipient body or donor cells could be collected directly to prepare CAR-T to prevent recurrence and induce relapsing. 3)MRD (+) was repeatedly difficult to treat drug-resistant cases. 4)It is difficult to cure extramedullary lesions (chest, abdominal cavity, bone, etc.). (2) The patients who had been transplanted were eligible for recurrence no matter what treatment they had before; (3) The pregnant women of childbearing age were negative in the urine pregnancy test before the administration, and agreed to take effective contraceptive measures during the trial until the last follow-up; 4. All, NHL and mm are applicable standards: (1) The age was 13 years old and less than 70 years old; (2) The total bilirubin of serum was less than 51 mol/l, ALT and AST were less than 3 times the upper limit of normal value, and creatinine = 92%; (5) The estimated life span is more than 3 months; (6) ECOG score 0-2; (7) Subject who meets the above standards will voluntarily participate in the trial and sign informed consent (subjects without full civil capacity shall sign the subject and their legal guardian jointly) on the premise of participating in the research of "CD19 CAR-T cell therapy for ALL and NHL, or BCMA CAR-T cell therapy for MM"in our center.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of epilepsy or other central nervous system diseases; 2. Patients with prolonged QT or severe heart disease in the past; 3. Pregnant or lactating women (the safety of this therapy for unborn children is unknown); 4. The patients with active infection were not cured; 5. Patients with active hepatitis B or hepatitis C virus infection; 6. In response to CD3 / CD28 costimulatory signal, the amplification ability was insufficient ( 2.5mg/dl or ALT / AST > 3 times normal or bilirubin > 2.0mg/dl; 8. Those who suffer from other uncontrolled diseases and are considered unsuitable by the researchers; 9. HIV infected people; 10. Any situation that the researcher believes may increase the risk of the subject or interfere with the test results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nutritional status;adverse events; | — |
Countries
China
Contacts
Public ContactDing Shuyi
The First Affiliated Hospital, School of Medicine, Zhejiang University
Outcome results
None listed