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| Name | Class |
|---|---|
| Shanghai Liquan Hospital | OTHER |
| Ruijin Hospital | OTHER |
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This is a multicenter, open-label, non-randomized, single-arm clinical trial. Patients with relapsed/refractory multiple myeloma accompanied by extramedullary infiltration will receive BCMA - GPRC5D CAR-T cell therapy.
The primary objective is to prospectively evaluate the safety of dual-targeting BCMA and GPRC5D CAR - T cell therapy for extramedullary infiltration in relapsed/refractory multiple myeloma. The primary endpoints are to assess the type and incidence of dose-limiting toxicity (DLT) within one month after the reinfusion of BCMA-GPRC5D CAR-T cells in patients, as well as the incidence and severity of adverse events within one month after the reinfusion. It is expected that no more than 18 participants will be recruited.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dual-targeting BCMA-GPRC5D CAR-T cell therapy | Experimental | Patients receive dual-targeting BCMA-GPRC5D CAR-T cell therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual-targeting BCMA-GPRC5D CAR-T cell infusion | Drug | Approximately 3-5 days prior to BCMA-GPRC5D CAR-T cell infusion, subjects are treated with FC regimen (fludarabine and cyclophosphamide) for lymphodepletion. CAR-T cell infusion are performed 48 h after completion of chemotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) | Incidence and type of dose-limiting toxicity(DLT) within 1 month of BCMA-GPRC5D CAR-T infusion. | 30 days |
| Adverse events (AEs) | Total number, incidence and severity of adverse events (AEs) within 30 days of BCMA-GPRC5D CAR-T infusion | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Overall remission rate (ORR) | The assessment of ORR by dose group at 90 Days after BCMA-GPRC5D CAR-T infusion. | 90 days |
| Event Free Survival (EFS) | Evaluate the EFS of dual-targeting BCMA-GPRC5D CAR-T cell therapy for extramedullary infiltration in relapsed and refractory multiple myeloma |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yao Yao | Contact | 86+13101898518 | yaoy01@gobroadhealthcare.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Liquan Hospital | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054219 | Neoplasms, Plasma Cell |
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| from enrollment to the end of treatment at 2 years |
| Duration of Response (DOR) | Evaluate the DOR of dual-targeting BCMA-GPRC5D CAR-T cell therapy for extramedullary infiltration in relapsed and refractory multiple myeloma | from enrollment to the end of treatment at 2 years |
| Overall Survival (OS) | Evaluate the OS of dual-targeting BCMA-GPRC5D CAR-T cell therapy for extramedullary infiltration in relapsed and refractory multiple myeloma | from enrollment to the end of treatment at 2 years |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |