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This is a prospective, single-arm, multicenter, open-label study to evaluate the efficacy and safety of aponermin-based bridging therapy prior to CAR-T infusion in relapsed/refractory multiple myeloma patients with extramedullary disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aponermin-based regimen bridging CAR-T therapy | Experimental | Patients will receive aponermin-based bridging therapy followed by Fc-based conditioning and CAR-T cell infusion. One month after CAR-T cell therapy, patients will begin maintenance therapy for at most 6 months or until disease progression, death, intolerance, withdrawal for other reasons, or the study's termination/completion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-BCMA/GPRC5D bispecific CAR-T | Biological | Autologous BCMA/GPRC5D bispecific CAR-T cells, infusion intravenously at a target dose of 2-4 x 10^6 anti-BCMA/GPRC5D bispecific CAR-T cells/kg. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | The definition of ORR is the proportion of participants who achieve a PR or better as the best response according to the IMWG criteria. | within 1 months after BCMA/GPRC5D CAR-T infusion |
| Measure | Description | Time Frame |
|---|---|---|
| ORR before CAR-T cell infusion | ORR before CAR-T cell infusion is defined as the proportion of participants who achieve a confirmed PR or better as the best response after conditioning treatment but prior to CAR-T cell infusion. | before CAR-T cell infusion |
| Progression free survival(PFS) |
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Inclusion Criteria:
Exclusion Criteria:
9) Patients with severe autoimmune diseases. 11) Any other reasons deemed unsuitable for participation in this study as determined by the investigator.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gang An, PhD&MD | Contact | 86-022-23909171 | angang@ihcams.ac.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Gobroad Boren Hospital | Recruiting | Beijing | China |
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| Apornemin | Drug | Apornemin 10mg/kg will be administered by i.v. infusion. Apornemin will be administered on Days 1-5, 15-19 during bridging therapy, and on Days 1-5 every 28-day cycle during maintanance treatment. |
|
| Carfilzomib | Drug | Carfilzomib 27mg/m^2 will be administered by i.v. on Days 1,2,8,9 during bridging therapy. |
|
| Thalidomide | Drug | Thalidomide (150mg/d) will be administered by p.o. on Days 1-14 during bridging therapy, and Days 1-28 every 28-day cycle during maintanance treatment. |
|
| Dexamethasone | Drug | Dexamethasone (20mg/d) will be administered by i.v. or p.o. on Days 1-4,8,9 during bridging therapy. |
|
Progression free survival is defined as the time from the start of Aponermin treatment to disease progression, as defined in the IMWG criteria, or death due to any cause, whichever occurs first. |
| Up to 2 year |
| Overall Survival (OS) | Overall Survival (OS) is defined as the time from the start of Aponermin treatment to the date of the participant's death. | Up to 2 year |
| Adverse events and serious adverse events | Adverse events (AEs), serious adverse events (SAEs), and assessments of clinical laboratory values | Up to 2 year |
| Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences | Recruiting | Tianjin | China |
|
| ID | Term |
|---|---|
| C524865 | carfilzomib |
| D013792 | Thalidomide |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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