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This study is a prospective, single-arm, multicenter trial designed to evaluate the hematologic response rate and safety of BCMA/CD3 bispecific antibody bridging therapy prior to CAR-T cell infusion in patients with relapsed/refractory multiple myeloma (RRMM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CM336 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM336 (BCMA/CD3 bispecific antibody) | Biological | CM336 is a BCMA × CD3 bispecific antibody. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | The proportion of subjects achieving stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) after treatment with CM336 injection | Minimum 2 years after infusion |
| Safety and Tolerability | The incidence of treatment-emergent adverse events (TEAES) | Minimum 2 years after infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Response (TTR) | Time from first BCMA × CD3 bispecific antibody infusion to first hematologic response, Depth of best hematologic response: The highest-level response achieved at any timepoint. | Minimum 2 years after infusion. |
| Duration of Response (DOR) |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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Duration of response (DOR) was defined as the time from first documented hematologic response (≥ partial response [PR]) to disease progression or death due to progression, whichever occurred first |
| Minimum 2 years after infusion |
| Overall Survival (OS) | Minimum 2 years after infusion |
| Progression-Free Survival (PFS) | Minimum 2 years after infusion |
| 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 |