Multiple Myeloma
Conditions
Interventions
Case series:CART-BCMA&PD-1 infusion
Sponsors
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Chinese subjects >=18 years of age; 2. Documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria. 3. Measurable disease at Screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level >=1.0 g/dL or urine M-protein; level >=200 mg/24 hours; or Light chain multiple myeloma* without measurable disease in the serum or the urine: Serum immunoglobulin free light chain >=10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio; *specific definition in this study: multiple myeloma with only FLC measurable, no M protein meets the measurable criteria in serum or urine. 4. Received at least 3 prior lines of treatment for multiple myeloma, undergone at least 1 complete cycle of treatment for each line, unless PD was documented by IMWG criteria as the best response to the regimen; 5. Received a PI and an IMiD; 6. Subject must have documented evidence of progressive disease based on investigators determination of response consistent with IMWG criteria on or after within 12 months of their last regimen. Non-responsive disease is defined as either failure to achieve minimal response or development of progressive disease (PD) while on therapy. Also, subjects with documented evidence of progressive disease (as above) within the previous 6 months and who are refractory or non-responsive to their most recent line of treatment afterwards are eligible; 7. ECOG Performance Status grade of 0 or 1.
Exclusion criteria
Exclusion criteria: 1.Diagnosed or treated for invasive malignancy other than multiple myeloma, except: (1) Malignancy treated with curative intent and with no known active disease present for >=2 years before enrollment; or (2) Adequately treated non-melanoma skin cancer without evidence of disease; 2. Prior antitumor therapy as follows, prior to apheresis: (1) Targeted therapy, epigenetic therapy, or treatment with an investigational drug or used an invasive investigational medical device within 14 days or at least 5 half -lives, whichever is less; (2) Monoclonal antibody treatment for multiple myeloma within 21 days; (3) Cytotoxic therapy within 14 days; (4) Proteasome inhibitor therapy within 14 days; (5) Immunomodulatory agent therapy within 7 days; (6) Radiotherapy within 14 days. However, if the radiation portal covered =70 mg of prednisone within 7 days prior to apheresis 6. Received either of the following: (1) An allogeneic stem cell transplant for multiple myeloma; (2) An autologous stem cell transplant 2.0x10^9/L plasma cells by standard differential), Waldenstr?ms macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary AL amyloidosis; 10. Seropositive for human immunodeficiency virus (HIV); 11. Vaccinated with live, attenuated vaccine within 4 weeks prior to apheresis; 12. Hepatitis B infection. In the event the infection status is unclear, quantitative levels are necessary to determine the infection status; 13. Hepatitis C infection defined as anti-hepatitis C virus [HCV] antibody positive, quantitative HCV-RNA positive, or known to have a history of hepatitis C. For subjects with known history of HCV infection, confirmation of sustained virologic response (SVR) is required for study eligibility, defined as >=24 weeks after completion of antiviral therapy; 14. Supplemental oxygen use to maintain adequate oxygenation; 15. Serious underlying medical condition, such as: (1) Evidence of serious active viral, bacterial, or uncontrolled systemic fungal infection; (2) Active autoimmune disease or a history of autoimmune disease within 3 years; (3) Overt clinical evidence of dementia or altered mental status; 16. Pregnant or breast-feeding, or planning to become pregnant while enrolled in this stud
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety; | — |
Countries
China
Contacts
Public ContactJianqing Mi
Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed