Multiple myeloma
Conditions
Interventions
Intervention group:The BCMA/NKG2DL/FAP-targeted HLA-independent TCR-T cells
Sponsors
First People’s Hospital of Foshan
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age 18–75 yearsno gender limitation 2.Bone marrow patients who were diagnosed as relapsed or refractory and met the following criteria: a) Had received 2 or more lines of multiple myeloma therapy (including proteasome inhibitors, immunomodulators, and/or monoclonal antibodies) and had disease progression or recurrence during or after the most recent therapy. Note: 1 or more cycles of planned therapy are considered as "1 line therapy" : induction chemotherapy, stem cell transplantation, and maintenance therapy (if no disease progression occurs between them) are considered as 1 regimen 3.Patients with one or more measurable multiple myeloma lesions must include any of the following: a) Serum M protein greater than or equal to 1.0g/dL (10g/L)b) Urine M protein greater than or equal to 200mg/24h;c) Serum free light chain (sFLC) detection: abnormal k/FLC ratio and FLC involvement of 210mg/dL;d) Bone penetrating bone marrow smear: marrow plasma cells =30% 4.Malignancy documented to express BCMA, NKG2DL, FAP based on immunohistochemical staining 5.European Cooperative Oncology Group (ECOG) performance status of 0 to 2 inclusive 6.Echocardiography showed normal diastolic function,without severe arrhythmia,LVEF=50% 7.No serious pulmonary, hepatic or renal disease, or active lung infection. Oxygen saturations >92% on room air. 8.Have no contraindications to peripheral blood apheresis 9.Life expectancy from non-Multiple myeloma- related causes of >12 months.
Exclusion criteria
Exclusion criteria: 1.History of other tumors in the last 2 years 2.Have had autologous hematopoietic stem cell transplant within six weeks 3.Uncontrolled active infection 4.HIV-infected 5.Being treated with biological therapies, chemotherapy or radiation 6.Stem cell transplantation within the preceding 3 months or still requiring systemic immunosuppression 7.Active autoimmune disease requiring systemic immunosuppression 8.Active CNS pathology including: epilepsy, seizure within the preceding year, aphasia, paresis, stroke, dementia, psychosis within the preceding year, severe brain injury, Parkinson disease or cerebellar disease 9.Pregnant or lactating female 10.The researchers considered that there were other conditions in which the subjects were not eligible to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CR;PR;ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;DFS;DOR;BOR;OS;TTR; | — |
Countries
China
Contacts
Public Contactying Zhao
First People’s Hospital of Foshan
Outcome results
None listed