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This study is an open-label, single-arm, dose-escalation and expansion, prospective clinical trial. It enrolls patients with relapsed/refractory plasma cell disorders, administers GPRC5D CAR-T cell therapy, follows up to observe adverse reactions after medication, collects relevant data on treatment efficacy, evaluates the safety and efficacy of CAR-T cells, and simultaneously investigates the cellular kinetic characteristics of CAR-T cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GPRC5D CAR-T cell intravenous infusion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GPRC5D CAR-T cell intravenous infusion | Biological | GPRC5D CAR-T cell intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Monitor and record adverse events | up to two years after the CAR-T cell infusion | |
| Overall Response Rate | up to two year after the CAR-T cell infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Cell pharmacokinetics Dynamic indicators | CAR-T/T% by flow cytometry | up to one month after the CAR-T infusion |
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Inclusion Criteria:
Subjects must meet all of the following criteria:
Exclusion Criteria:
Any of the following conditions will not be eligible for enrolment:
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| ID | Term |
|---|---|
| D010265 | Paraproteinemias |
| ID | Term |
|---|---|
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
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| D007154 | Immune System Diseases |