BCMA-positive relapsed/refractory multiple myeloma
Conditions
Interventions
Experimental group:Ori-CAR-002 T infusion
Sponsors
Renji Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Subjects who are willing to participate in the study can understand and have the ability to sign an informed consent form; 2. According to the 2018 IMWG standard, MM was diagnosed. During the course of the subject's disease, the monoclonal plasma cells in the bone marrow had been >= 10% or the biopsy confirmed the presence of plasmacytoma; 3. No gender limit, aged 18-70 years (calculate the subject's age based on the date of signing the informed consent form), and the expected survival period is not less than 12 weeks; 4. Use flow cytometry or immunohistochemistry to detect bone marrow or plasmacytoma specimens, and BCMA expression can be detected on > 20% of malignant plasma cells; 5. The presence of measurable lesions during screening is defined as any of the following conditions: serum M protein >=1 g/dL (>=10 g/L), if subjects with IgA, IgD, IgE or IgM multiple myeloma, then Serum M protein >=0.5 g/dL (>=5 g/L); or urine M protein level >=200 mg/24 hours; or light chain type MM, no measurable foci in serum or urine, serum free light chain (sFLC) ) >=10 mg/dL (>=100 mg/L) and the ratio of k/? FLC is abnormal; or there are extramedullary lesions; 6. The subject has received at least 3 treatments that have failed, or the disease has progressed or recurred during the last treatment or after the end of the treatment; 7. The toxicity (including peripheral neuropathy) caused by previous treatments in the subject must be completely restored or stabilized to = 30 mL/min, serum ALT/AST = 30g/L, cardiac ejection fraction >= 50%, echocardiographic examination confirmed no pericardial effusion, no clinically significant ECG findings, no clinical Significant pleural effusion, baseline blood oxygen saturation in the room> 92%; 11. Possess sufficient venous access (for apheresis or venous blood collection), and there are no other apheresis contraindications; 12. Female subjects of childbearing age must undergo a serum pregnancy test at the time of screening, before receiving cyclophosphamide and fludarabine treatment, and before receiving the infusion of this research product, and the result is negative, and they are willing to use a very effective and reliable method of contraception within 1 year after the research treatment. The available methods are: bilateral tubal ligation/bilateral salpingectomy or bilateral tubal occlusion; or approved oral, injection or implantation of hormonal contraceptive methods; or barrier contraceptive method: containing spermicidal foam/ Gel/film/cream/suppository condom or occlusive cap (diaphragm or cervical/fornix cap); 13. If male subjects have active sexual life with women with reproductive potential, they must be willing to use very effective and reliable methods of contraception within 1 year after using the research treatment. The methods that can be used are: sterilization (vasectomy); obstruction method of birth control, for example, condoms containing spermicidal foam/gel/film/ointment/suppositories, or contraceptive methods for their spouse (see Article 12 of the selection criteria). More
Exclusion criteria
Exclusion criteria: 1. Allergic reactions to gentamicin, ampicillin or chemotherapy pretreatment drugs (cyclophosphamide, fludarabine, etc.), or immunotherapy-related drugs (such as tocilizumab, etc.), or immunoglobulin drugs , Hypersensitivity, intolerance or contraindication; 2. Received the following anti-MM treatments within 2 weeks: used monoclonal antibodies (MoAbs), proteasome inhibitors (PI), immunomodulatory drugs (IMiD), or cytotoxic treatments (such as radiotherapy and chemotherapy) within 2 weeks of subjects. Received radiotherapy within 2 weeks, but if the radiation field covers = 2 grade according to the New York Heart Association (NYHA), myocardial infarction occurred in the past 3 months before enrollment, or coronary artery bypass graft ( CABG), un
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Cmax;Disease control rate;0-28d area under the time curve;Duration of relief;Progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactHou Jian
Outcome results
None listed