multiple myeloma
Conditions
Interventions
Case series:CAR-T infusion
Sponsors
Drum Tower Hospital Affiliated to Nanjing University Medical School
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with multiple myeloma aged 18-75 years; 2. According to the IMWG diagnostic criteria, patients were confirmed diagnosis of multiple myeloma; 3. High-risk patients according to mSMART criteria (Mayo stratification of myeloma and risk-adapted therapy)must have >=1 prior anti-myeloma treatment regimens; 4. Relapse multiple myeloma patients according to NCCN2019 V1; 5. ECOG =30ml / min; total biliary red <=30 umol; 7. Women of childbearing age had negative urine pregnancy test before the start of the medication, and agreed to take effective contraceptive measures ((annual failure rate of <1% for continued and correct use)) from signing informed consent (ICF) to at least 100 days after cell infusion. Efficient contraceptive methods include: non-user dependent methods: 1) implantable progestogen contraceptives that inhibit ovulation; 2) intrauterine devices (IUD); intrauterine hormone release system; 3) sexual partner vasectomy; Usre-dependent methods: 1) Compounds that inhibit ovulation (including estrogen and progesterone) hormonal contraceptives: oral, vaginal, and transdermal; 2) progestogen contraceptives (oral or injectable) that inhibit ovulation; 8. In addition to high-efficiency contraceptive methods, male subjects should: consent to the use of barrier contraception when they have sex with a fertile woman signing informed consent (ICF) to at least 100 days after cell infusion. ( For example, condoms plus spermicidal foam/gel/film/emulsion/suppository); condoms must be used when having sex with pregnant women; women and men must agree not to donate eggs (eggs, oocytes) or sperm from signing informed consent (ICF) to at least 100 days after cell infusion. Note: Hormonal contraceptives may interact with research treatments to reduce contraceptive effects; 9. Willing and able to comply with the restrictions in this project; 10. Voluntary participation, good compliance, cooperate with experimental observation, and sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. History of another primary malignancy that requires intervention beyond surveillance , the following are exempt: malignant tumors that had undergone radical treatment, and no recurrence of the tumor within >=3 years before enrollment; 2. Previously received the following anti-tumor treatment (before blood collection): received chemotherapy, radiotherapy, targeted therapy, epigenetic therapy or experimental drug therapy within 14 days or at least 5 half-lives (whichever is shorter); 3. The following heart diseases occur: New York Heart Association (NYHA) stage III or stage IV congestive heart failure; myocardial infection, active angina pectoris, heart disease asthma, etc.; myocardial infarction 70); 11. According to the investigator's judgment, the ongoing treatments of the patient will affect the safety and effectiveness of the study; 12. Pregnant or lactating women; 13. With other uncontrolled diseases, the investigator ensure that it is not suitable for enrollment; 14. Any cases that the investigator believes enrollment may increase the risk of the patient or interfere with the outcome of the study; 15. Patients who participate in other clinical trials at the same time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate;rate of adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;overall survival,;The amplification and persist of CAR-T in vivo; | — |
Countries
China
Contacts
Public ContactBing Chen
Drum Tower Hospital Affiliated to Nanjing University Medical School
Outcome results
None listed