Recruit
Inclusion Criteria
1．
adult at the age of 18 or above (inclusive of 18), female or male
2．
patients with multiple myeloma who have adopted at least 3 prior lines of systematic MM therapy and have failed at least proteasome inhibitors and immunomodulators;
at least 1 complete treatment cycle for each line of therapy; PD must be documented during or within 12 months after receiving the last treatment
at least 1 complete treatment cycle for each line of therapy; PD must be documented during or within 12 months after receiving the last treatment
3．
presence of measurable lesions at screening, defined as any of the following:
• Serum M-protein ≥ 1 g/dL (≥ 10 g/L)
• Urine M-protein ≥ 200 mg/24 hours
• Serum free light chain (FLC): abnormal serum FLC ratio (< 0.26 or > 1.65) and affected FLC ≥ 10 mg/dL (100 mg/L)
• Serum M-protein ≥ 1 g/dL (≥ 10 g/L)
• Urine M-protein ≥ 200 mg/24 hours
• Serum free light chain (FLC): abnormal serum FLC ratio (< 0.26 or > 1.65) and affected FLC ≥ 10 mg/dL (100 mg/L)
4．
ECOG score 0 ~ 2
5．
Expected survival time ≥ 3 months
6．
Subjects volunteer to participate in this clinical study, are fully aware of the study and have signed the Informed Consent Form (ICF).
Exclusion Criteria
1．
Have a history of severe allergic reactions
2．
Had prior anti-MM treatment within the specified time frame before lymphodepletion:
• The time of last treatment of small-molecule targeted drugs is less than 2 weeks or 5 half-lives of the drug (whichever was longer)
• The time of last treatment of macromolecular drug is less than 4 weeks or 2 half-lives of the drug (whichever was longer)
• The time of the last treatment of the cytotoxic drug therapy and/or Chinese medicine with anti-tumor indications is less than 2 weeks
• The time of the last treatment of the Immunomodulators is less than 1 week
• The time of last treatment of small-molecule targeted drugs is less than 2 weeks or 5 half-lives of the drug (whichever was longer)
• The time of last treatment of macromolecular drug is less than 4 weeks or 2 half-lives of the drug (whichever was longer)
• The time of the last treatment of the cytotoxic drug therapy and/or Chinese medicine with anti-tumor indications is less than 2 weeks
• The time of the last treatment of the Immunomodulators is less than 1 week
3．
the time of the last live or attenuated vaccine injection is less than 4 weeks
4．
Adverse effects of previous therapy have not yet returned to NCI-CTCAE grade 5.0 ≤1 (Including peripheral neuropathy)
5．
Have a history of cardiovascular diseases; had myocardial infarction less than 6 months before lymphodepletion; had unstable angina less than 3 months before lymphodepletion, with clinical symptoms were deemed by investigator as serious arrhythmia or had coronary artery bypass graft
6．
Pregnant or lactating women
Treatment Process
chemo- lymphodepletion
01
BCMA CAR-NK cell infusion
02
Therapeutic monitoring
03
Efficacy evaluation
04
Follow-up
05
Potential Adverse Events
Cytokine Release Syndrome, CRS
Symptoms: Fever, asthenia,
hypotension, dyspnea
hypotension, dyspnea
Treatment: treating specific symptoms;
IL-6 receptor antagonist etc
IL-6 receptor antagonist etc
Immune effector cell-related neurotoxicity syndrome
Symptoms: change in mental status, agitation,
depression, expressive aphasia or seizures, syncope
depression, expressive aphasia or seizures, syncope
Treatment: Glucocorticoid