This study is an investigator-initiated, single-center, single-arm clinical study with a target population of patients with relapsed or refractory multiple myeloma.
It is an early exploratory clinical study evaluating the safety, tolerability, and preliminary efficacy of PICX Injection, an in vivo prepared CAR-T cell therapy, in the treatment of relapsed or refractory multiple myeloma.
Inclusion Criteria:
Age ≥ 18 years, male or female;
Confirmed diagnosis of multiple myeloma meeting at least one of the following criteria:
At least one measurable disease indicator:
No evidence of extramedullary plasmacytoma (soft tissue plasmacytoma);
ECOG performance status score 0-2;
Expected survival period ≥ 3 months;
Adequate bone marrow function within 1 month prior to screening:
Adequate vital organ function within 1 month prior to screening:
Women of childbearing potential must have a negative pregnancy test during the screening period and before study drug administration, and must not be lactating during the study;
Men and women of childbearing potential must agree to use effective contraceptive measures (excluding unreliable methods such as rhythm method) from the time of signing the informed consent form until 1 year after the last dose of study drug, and must agree not to donate sperm or eggs;
The subject or their legally authorized representative has signed the informed consent form (ICF), indicating understanding of the study purpose and procedures and voluntary participation.
Exclusion Criteria:
Prior treatment with CAR-T therapy or other gene-modified cell therapy before screening;
Presence of active central nervous system (CNS) involvement at screening (including brain parenchymal, meningeal, or spinal meningeal involvement, or positive cerebrospinal fluid for tumor cells), or other CNS diseases;
Received the following anti-tumor therapies prior to PICX Injection infusion:
Active or uncontrolled infection requiring systemic treatment at screening (including bacterial, viral, fungal, or other infections);
Presence of any of the following cardiac conditions:
Presence of other clinically significant diseases or conditions, including:
Grade 2-4 acute graft-versus-host disease (GVHD) or moderate to severe chronic GVHD within 4 weeks prior to screening;
History of other malignancies other than multiple myeloma prior to screening, except for:
Vaccination with live-attenuated vaccine within 4 weeks prior to screening;
Known severe hypersensitivity to PICX Injection or any of its formulation components;
Inability to establish venous access;
Other conditions deemed by the investigator to be unsuitable for participation in the study.
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