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| Name | Class |
|---|---|
| Immix Biopharma, Inc. | INDUSTRY |
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The purpose of this study is to evaluate the efficacy and safety of NXC-201 compared with Dara-CyBorD (daratumumab-cyclophosphamide-bortezomib-dexamethasone) in the treatment of newly diagnosed amyloid light chain (AL) amyloidosis participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NXC-201 | Experimental | NXC-201 CAR-T |
|
| Daratumumab plus CyBorD | Active Comparator | Daratumumab plus CyBorD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NXC-201 | Biological | NXC-201 CAR-T is defined as autologous T cells transduced ex-vivo with anti-BCMA CAR retroviral vector encoding a proprietary chimeric antigen receptor (CAR) targeted to human BCMA. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall complete hematologic response (CHR) rate using consensus recommendations for AL amyloidosis treatment response criteria per protocol | CHR rate is defined as percentage of participants who achieved CHR | 24 months |
| Major Organ Deterioration Progression-Free Survival (MOD-PFS) | MOD-PFS is defined as duration from the date of randomization to either hematologic progression, or major organ deterioration (clinical manifestation of cardiac failure or renal failure), or death, whichever occurs first | 60 months |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined inclusion/exclusion criteria apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Trial Operations | Contact | 888-958-1084 | clinicaltrials@nexcella.com |
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| Dara-CyBorD | Drug | Daratumumab plus CyBorD combination |
|
| ID | Term |
|---|---|
| D000686 | Amyloidosis |
| ID | Term |
|---|---|
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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