Refractory/relapsed multiple myeloma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) According to the International Myeloma Working Group (IMWG), it is diagnosed as relapsed and refractory multiple myeloma, after at least 3 lines (including proteasome inhibitors and immunomodulator-based chemotherapy regimens), including continuous induction chemotherapy, Stem cell transplantation and maintenance treatment, if there is no disease progression between treatments, it is regarded as a treatment plan; there is disease progression evidenced by examination data during the most recent anti-myeloma treatment or within 12 months after the treatment; including autologous CART cell therapy is invalid Or patients with disease progression and relapse after six months of autologous hematopoietic stem cell transplantation. 2) Male or female patients, aged 18-70 years (including 18 years old); 3) No severe allergies; 4) Physical fitness score 0-2 points; 5) Estimated survival time >= 90 days; 6) Tumor specimens (blood, bone marrow, plasmacytoma and other specimens) have positive expression of BCMA (CD269) antigen after immunohistochemistry or flow cytometry; 7) Relative donors can collect enough lymphocytes and hematopoietic stem cells; 8) The patient voluntarily signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Intracranial hypertension or brain consciousness disorder; 2) Symptomatic heart failure or severe arrhythmia; 3) Symptoms of severe respiratory failure; 4) With other types of malignant tumors; 5) Diffuse intravascular coagulation; 6) Serum creatinine and/or urea nitrogen >= 1.5 times the normal value; 7) Suffer from sepsis or other infections that are difficult to control; 8) Suffer from uncontrollable diabetes; 9) Severe mental disorder; 10) There are active or uncontrolled central nervous system diseases; 11) Have received organ transplantation (excluding autologous hematopoietic stem cell transplantation); 12) Female patients (patients with fertility) have a positive blood HCG test; 13) Active hepatitis (including positive copy number of hepatitis B DNA and hepatitis C RNA) and positive screening for AIDS and syphilis. 14) DSA (anti-kin donor specific antibody) positive; 15) Participating in other interventional clinical studies when signing the informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation index;Pharmacokinetic evaluation index;Curative effect evaluation index; | — |
Countries
China
Contacts
Beijing Boren Hospital