Patients with Relapsed/Refractory Multiple Myeloma Anti-BCMA CAR5 T Cells CAR T Cells Refractory Multiple Myeloma Relapsed Multiple Myeloma Multiple Myeloma
Conditions
Interventions
There are 5 levels of dose such as Level -1 (125,000 cells/kg), Level 1 (250,000 cells/kg), Level 2 (500,000 cells/kg), Level 3 (750,000 cells/kg), and Level 4 (1,000,000 cells/kg), escalating dose in
Experimental Biological/Vaccine
Anti-BCMA CAR5 T Cells
Sponsors
Mahidol University
Foundation of Mr. Carsten Friis Jespersen
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Male or female, Age 18 to 70 years old 2. ECOG less than or equal 2 and the excepted survival more than or equal 3 months 3. Subjects must have been diagnosed as relapsed and or refractory multiple myeloma with all of 3.1 Treated with at least two lines of therapy 3.2 There were no assessable novel agents including bortezomib, thalidomide, lenalidomide, pomalidomide, carfilzomib, or daratumumab. 3.3 Disease must have either progressed after the last regimen or presented failure to achieve at least partial remission with the last regimen. 4. The main organs function is good; 4.1 liver function such as ALT or AST less than 3 times normal value upper limit (ULN) and total bilirubin less than 34.2 mol per L 4.2 renal function: creatinine less than 220 mu/L, GFR more than 30 mL/min 4.3 lung function such as blood oxygen saturation is greater than 95% 4.4 cardiac function such as left ventricular ejection fraction (LVEF) is greater than 50% 5. Platelets more than 40 billion/L 6. Patients without any anti-cancer treatment such as chemotherapy, radiotherapy, immunotherapy (immunosuppressive drugs) within 2-4 weeks before, and the treatment-related toxicity reaction less than or equal 1 level prior to enrollment (except low toxicity lose hair for example) 7. Venous channel is unobstructed, which can meet the needs of intravenous drip 8. Voluntary informed consent is given, agree to follow the trial treatment and visit plan
Exclusion criteria
Exclusion criteria: 1. Patients with allergy to large molecules such as antibodies or cytokines 2. More than 5mg of hormones (except patients with inhaled hormone) were used within 2 to 4 weeks prior enrollment 3. Patients with severe autoimmune diseases or immunodeficiency diseases 4. Patients treated with other immune cellular products (DC, CIK, T, NK, and CART products with CD19 or other targets) 5. Patients with uncontrollable infectious disease in the first 4 weeks of treatment 6. Active hepatitis B DNA more than 1000 copy/mL , hepatitis C positive, (HCV positive resistance, HCV RNA positive) 7. Patients participated in other clinical trials within 6 weeks prior enrollment 8. Patients with mental illness 9. Patients with drug abuse or addiction and medical, psychological or social conditions may interfere with the study or evaluate the results of the study 10. Patients have alcohol dependence 11. Pregnant or lactating women, Men or women who have a pregnancy plan within a year, The patients cannot guarantee effective contraceptive measures during the trial period 12. Patients had other conditions that were not appropriate for the group determined by the researchers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Suspected adverse events within 84 days after the 1st dose of anti-BCMA CAR5 T cells Number of adverse events,Suspected serious adverse events within 84 days after the 1st dose of anti-BCMA CAR5 T cells Number of serious adverse events,maximum tolerated dose within 28 days after the 1st dose of anti-BCMA CAR5 T cells defined based on the dose limiting toxicity (DLT),autologous anti-BCMA CAR T cell products at 28 days that meet the specified release criteria number of autologous anti-BCMA CAR T cell products | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate within 15 years after end of the anti-BCMA CAR5 T cells treatment assessed using standard response criteria for multiple myeloma using IMWG 2016 criteria,Progression free within 15 years after end of the anti-BCMA CAR5 T cells treatment time of stable disease that assessed using disease evaluations,overall survival within 15 years after end of the anti-BCMA CAR5 T cells treatment time of survival | — |
Countries
Thailand
Contacts
Public ContactChutima Kunacheewa
Faculty of Medicine Siriraj Hospital
Outcome results
None listed