acute myeloid leukemia
Conditions
Interventions
Experimental group:the anti-B7-H3 CAR T cells were transfused
Sponsors
Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Chinese subjects aged 18 to 70 years when signing the informed consent; 2. ECOG physical status level is 0 or 1, and the expected survival time is >= 3 months; 3. Patients with one of the following conditions: (1) Patients with AML who have not achieved complete remission after standard chemotherapy; (2) AML patients who did not meet, were not eligible or refused allogeneic hematopoietic stem cell transplantation; 4. The expression of B7-H3 in malignant cells must be detected by immunohistochemistry or flow cytometry; 5. The clinical laboratory values during screening period met the following criteria: (1) Creatinine = 90%; (3) Total bilirubin = 80g/L; 6. The patient did not receive any chemotherapy, radiotherapy, immunotherapy (such as immunosuppressive drugs/corticosteroids) or other anticancer treatment within 2 weeks before signing the informed consent; 7. Intravenous access for mononuclear cell collection, and no other contraindications; 8. Fertile women must be negative for a highly sensitive serum pregnancy test (ß chorionic gonadotropin) at screening time and before initial treatment with cyclophosphamide and fludarabine; Fertile subjects will receive effective medical contraception (for both men and women, at least 36 months after signing the informed consent form until receiving the anti-B7-H3 CAR T cell infusion). See Annex 4 for specific contraceptive measures; 9. After the discussion of the expert group, the patient's condition was analyzed, and combined with the general physical condition of the patient, the benefits of participating in the clinical trial outweigh the risks; 10. Subjects must obtain and sign informed consent, indicating that they understand the purpose and procedures of the study, are willing to participate in the study, and are able to comply with the contraindications and limitations specified in the protocol.
Exclusion criteria
Exclusion criteria: 1.Have been diagnosed or treated for malignancies other than AML in the 5 years prior toscreening, except for adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer; Or local prostate cancer or ductal carcinoma in situ after radical treatment; 2.Serious systemic disease: NYHA stage III or IV congestive heart failure; Had a cerebrovascular accident or myocardial infarction or arrhythmia causing hemodynamic instability within 6 months before signing the informed consent; Impaired cardiac function as assessed by echocardiographic scan (LVEF = 5/µL white blood cells (WBCs) in cerebrospinal fluid (CSF), positive protocell centrifuge smear (in the absence of a traumatic lumbar puncture), and/or clinical signs of CNS leukemia, such as cranial nerve palsy due to active disease]; Patients with central nervous system leukemia who receive adequate treatment are eligible; 6.Human immunodeficiency virus (HIV) positive serum; The subject is positive for hepatitis B surface antigen or HBV DNA is higher than the detection limit of analysis method; Positive hepatitis C antibody or HCV RNA is higher than the detection limit of the analytical method; The subjects were positive for syphilis antibody and rapid plasma reactivity hormone; CMV DNA positive; 7.Have a known life-threatening allergic reaction to B7-H3 CAR T cells or their excipients, including dimethyl sulphone (DMSO); Allergy constitution, allergy to antibodies or cytokines and other biological macromolecular drugs; 8.Contraindications for fludarabine or cyclophosphamide; 9.Received systemic corticosteroid therapy at a dose greater than 20mg/d of prednisone (or equivalent dose of another corticosteroid) within 2 weeks prior to rinsing; 10.Alcohol dependence, drug abuse and mental disorders; 11.Other circumstances that the researcher considers inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total response rate (ORR);Progression-free survival time (PFS);Overall survival rate (OS);Safety; | — |
Countries
China
Contacts
Public ContactXu Kailin
Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed