This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of bispecific BCMA-GPRC5D CAR-T cells in patients with relapsed or refractory multiple myeloma who received three or more lines of therapy.
The patient or his/her guardian understands and voluntarily signs the informed consent, and is expected to complete the follow-up examination and treatment of the study procedure;
Age 18-75 years old, gender unlimited;
Diagnosed as Multiple Myeloma (MM) according to the international standard for multiple myeloma (IMWG);
The presence of measurable disease at screening meets one of the following criteria:Serum M-protein ≥ 1.0 g/dL or Urine M-protein ≥ 200 mg/24h or diagnosed as Light-chain MM without measurable disease in serum and urine; Serum free light chain ≥ 10 mg/dL with an abnormal κ/λ ratio;
Have been diagnosed with or treated for aggressive malignancies other than multiple myeloma;
Prior antitumor therapy (prior to blood collection for CAR-T preparation) : targeted therapy, epigenetic therapy, or investigational drug therapy within 14 days or at least 5 half-lives, whichever is shorter;
It is suspected that MM has involved the central nervous system or meninges and has been confirmed by MRI or CT, or there are other active central nervous system diseases;
Patients with Fahrenheit macroglobulinemia, POEMS syndrome, or primary AL, amyloidosis;
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Lead sponsor
Guangzhou Bio-gene Technology Co., Ltd
Collaborator