Relapsed and refractory multiple myeloma
Conditions
Interventions
low dose group:Infusion of 300x10^6 total CAR positive cells
medium dose group:Infusion of 600x10^6 total CAR positive cells
high dose group:Infusion of 900x10^6 total CAR positive cells
Sponsors
Tangdu Hospital, Fourth Military Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subjects are willing to participate in this clinical study and sign the informed consent; 2. Aged >= 18 years old; 3. Previously diagnosed with multiple myeloma (and BCMA positive) according to the IMWG diagnostic criteria; 4. Has measurable lesions; 5. Received protease inhibitors and an immunomodulator (except thalidomide); 6. Experienced at least three lines of treatment in the past and each line of treatment is a complete course of treatment. Except in patients with PD as defined by the IMWG best response, or patients who are refractory or previously intolerant to any protease inhibitor or any immunomodulatory agent; 7. Pre-survival time >= 3 months.
Exclusion criteria
Exclusion criteria: 1. No response to BCMA CAR-T therapy (except for relapse after complete remission after previous BCMA CAR-T therapy); 2. Previous experience with BCMA-targeted monoclonal antibody therapy; 3. Other invasive malignant tumors that were previously diagnosed or treated for non-multiple myeloma, with the following exceptions: the malignant tumor has been cured for at least 2 years and no active lesions are found; the effectively treated non-melanoma skin cancer has no existing lesions; 4. Recent anti-tumor therapy (before pretreatment): patients treated with monoclonal antibodies within 21 days; after targeted therapy, epigenetic therapy, or treatment with unmarketed drugs and unmarketed invasive medical devices After 14 days, or at least five half-lives; within 14 days of cytotoxin-related therapy; within 14 days of protease inhibitor therapy; within 14 days of radiotherapy, but patients whose radiotherapy contains 2.0 x 10^9/L), Waldenstr?m macroglobulinemia, POEMS syndrome, or primary amyloidosis; 13. HIV seropositive; positive result of any of the following: hepatitis B surface antigen, hepatitis B pathogen DNA, hepatitis C antibody, hepatitis C virus RNA or HIV virus antibody; 14. Vaccination with live or attenuated vaccine within 4 weeks; 15. Known life-threatening allergy, hypersensitivity, or intolerance to CAR-T cells and their excipients such as DMSO; 16. Potentially serious medical symptoms, such as: definite severe viral, bacterial or uncontrollable fungal infection; active autoimmune disease or history of autoimmune disease within 3 years; dementia or mental condition with obvious clinical manifestations; history of Parkinson's disease or neurodegenerative diseases; 17. Other circumstances deemed unsuitable for inclusion by the investigator; 18. Men who plan to become pregnant or want to become pregnant within one year of treatment; women who are pregnant or are breastfeeding, or plan to become pregnant or plan to become pregnant within one year of treatment; 19. Surgical planner.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| complete remission rate;objective response rate; | — |
Countries
China
Contacts
Public ContactLiu Li
Tangdu Hospital, Fourth Military Medical University
Outcome results
None listed