CD99-positive hematologic malignancies
Conditions
Interventions
Treatment:CD99 CAR-T
Sponsors
The First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Subject participates in this clinical trial and sign Informed Consent Form voluntarily. 2.Aged 18 to 75 years, male or female; 3.Subjects with pathologically confirmed CD99-positive hematological malignancies and have been failed to at least first-one prior line of systemic treatment (ie chemotherapy, autologous hematopoietic stem cell transplantation) or voluntarily received anti-CD99 CAR-T as salvage regimen; 4.CD99-positive hematological malignancies as follows: 5.T mature T-cell lymphoproliferative disorders, T-cell LPD; 1)T-cell acute lymphoblastic leukemia/ lymphoma, T-ALL; 2)Acute myeloid leukemia, AML; 3)Myelodysplastic syndromes, MDS; 4)B-lymphoblastic lymphomas/leukemias; 5)Anaplastic large cell lymphomaALCL, particularly ALK-positive ALCL and systemic anaplastic large cell lymphomas; 6)Precursor T-Cell Lymphoblastic Leukemia/Lymphoma, T-LBL; 7)Angioimmunoblastic T-cell Lymphoma, AITL; 8)Peripheral T-cell lymphoma, PTCL; 9)Other CD99-positive lymphoproliferative tumors; 6.Subjects included: (1) having residual lesions and are not suited to auto/allo-HSCT; (2) relapse after CR and are not suited to auto/allo-HSCT; (3) having high-risk factors; (4) relapse or no response to auto/allo-HSCT and immunotherapy. 7.Disease must be measurable according to the corresponding guidelines. 8.Patient with adequate hepatic function (Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) = 95%) and cardiac function (Left ventricular ejection fraction of >= 40% by ECHO). 9.The blood flow of peripheral superficial vein was unobstructed, which meet the demand of intravenous infusion. 10.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or 2 and estimated life expectancy > 12 weeks;
Exclusion criteria
Exclusion criteria: 1.A woman who is pregnant or breastfeeding. 2.A Man or woman with pregnancy plans in one year. 3.Subjects can not ensure effective contraception (ie condoms or contraceptives) within one year after enrollment. 4.An uncontrolled infection illness within 4 weeks before enrollment. 5.Active HBV or HCV hepatatitis. 6.HIV-positive subjects 7.Subjects with serious auto-immune diseases and immuno compromised illness; 8.Allergic constitution who are allergic to macromolecular biopharmaceuticals including antibodies and cytokines. 9.Subjects who participated in other clinical trials within 6 weeks before enrollment. 10.Subjects who systematically received corticorsteroids (inhalation excluded) ; 11.Subjects who have mental illness or are addictive to drugs;
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| progression free survival;event free survival;overall survival;CAR-T persistence;CAR-T expansion; | — |
Primary
| Measure | Time frame |
|---|---|
| Safety profile;objective response rate;complete response; | — |
Countries
China
Contacts
Public ContactFei Li
The First Affiliated Hospital of Nanchang University
Outcome results
None listed