Refractory or Relapsed Multiple Myeloma
Conditions
Interventions
CAR T cell:CAR-BCMA T cell
Sponsors
Xin Hua Hospital of Shanghai Jiao Tong University of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged between 18 ~ 70 with relapsed or refractory multiple myeloma. 2. Bone marrow sample is confirmed as BCMA-positive by flow cytometry or pathological examination. 3. Patients with relapsed or refractory multiple myeloma who meet the following conditions: 1) Curative efficacy is little or disease progressed after 2 courses of standard treatment regimen; 2) Disease relapsed after chemotherapy or HSCT. Curative efficacy is little or disease progressed after 2 courses of original treatment regimen; 3) More than 60 days between last treatment and disease progression; 4) Autologous or allogeneic SCT is not available at present, or patient refuses to receive SCT; 5) Disease progression is defined as per Chinese Guidelines for Diagnosis and Treatment of Multiple Myeloma (Revision in 2015). At least one of the following conditions should be met: Serum M-protein increases = 25% (absolute increase should be = 5 g/L). If serum M protein is = 50 g/L at baseline, increase of serum M protein can be = 10 g/L; Urine M-protein increases = 25% (absolute increase should be = 200 mg/24 h); If the serum and urine M-protein are not detectable, a = 25% increase in the difference between involved and uninvolved FLC levels is required (absolute increase should be = 100 mg/L); Bone marrow plasma cell percentage increases = 25% (absolute increase should be = 10%); Size of existing bone lesions or soft tissue plasmacytomas increases by = 25%, or development of new lytic bone lesions or soft tissue plasmacytomas; Development of hypercalcemia that can be attributed to plasma cell proliferative disorder (corrected calcium is > 2.8 mmol/L or 11.5 mg/dL); Disease progression must be confirmed by 2 sequential assessments; 4. Expected survival > 12 weeks; 5. Disease is measurable, and at least one of the following conditions should be satisfied: 1) Serum M-protein is = 10 g/L; 2) 24-hour urine M-protein is = 200 mg; 3) Serum FLC is = 5 mg/dL; 4) Plasmacytomas that can be measured or evaluated by imaging; 5) Bone marrow plasma cell percentage is = 20%. 6. ECOG scores 0 - 1; 7. Adequate venous access for apheresis and venous blood sampling, and no other contraindications for leukapheresis; 8. WBC = 1.5×10^9/L; PLT = 45×10^9/L; 9. Serum creatinine = 1.5 ULN; 10. ALT = 2.5 ULN; AST = 2.5 ULN. The above lab results should not include those obtained from continuous supportive treatment that is ongoing.
Exclusion criteria
Exclusion criteria: Patients with any of the following conditions are not eligible for this study. 1. Transduction of target lymphocytes < 10%, expansion in response to aCD3/CD28 costimulation < 5-fold; 2. Pregnant or lactating women; 3. HIV positive, or HCV positive; 4. Uncontrolled active infection, including active tuberculosis and HBV DNA copies = 1×10^3 copies/mL; 5. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary; 6. Allergic to immunotherapies and related drugs; 7. Patients with heart disease for which treatment is needed or with poorly controlled hypertension; 8. Hyponatremia: serum sodium level < 125 mmol/L; 9. Baseline serum potassium < 3.5 mmol/L (taking potassium supplements before participating in the study to raise potassium level is acceptable); 10. Previous treatment with chemoradiotherapy, immunotherapy and tumor-targeting drug conducted 2 weeks prior to participation in this study or blood collection; 11. Patients have undertaken immunosuppressor for graft-versus-host disease (GVHD) within 4 weeks before participation in this study or blood collection, or the patient is diagnosed with acute or chronic GVHD; 12. Other severe disease that may restrain patients from participating in this study (e.g. diabetes, severe cardiac dysfunction, myocardial infarction or unstable arrhythmias or unstable angina in recent 6 months, gastric ulcer, active autoimmune disease, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with CAR-BCMA T cell therapy-related adverse events as assessed by CTCAE v4.03; | — |
Secondary
| Measure | Time frame |
|---|---|
| Engraftment; | — |
Countries
China
Contacts
Public ContactSiguo Hao
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed