구조모아 (StructureMoa)항암 chemical structure spider web
방문타깃 · 모달리티 · 임상 근거 · 비임상 맥락으로 최대 5개 프로그램을 나란히 비교합니다. · 다음 갱신 D-5 · 마지막 9월 2일
현재 선택: 2개 · Data Tier에서 열림
프로그램 상세에서 관심 등록 후 2개 이상 모으면 여기서 한 번에 비교할 수 있습니다.
표가 넓으면 좌우로 스크롤하세요. 핵심 비교 모드에서는 중요 항목만 표시됩니다.
| 항목 | teclistamab (Tecvayli, JNJ-64007957, teclistamab-cqyv) Johnson & Johnson·BCMA × CD3 132 trials·t½ ~2–3 weeks at steady state | |
|---|---|---|
Overview Program | Darzalex (daratumumab) | Tecvayli (teclistamab) |
Overview Company | Janssen | Johnson & Johnson |
Overview Modality | ANTIBODY | ANTIBODY |
Overview Target | CD38 | BCMA × CD3 |
Overview Indication | Multiple myeloma | Relapsed or refractory multiple myeloma |
Overview Phase | APPROVED | APPROVED |
Overview Status | APPROVED | APPROVED |
Overview Content status | Curated Core | Curated Core |
Overview Data Confidence | Data Confidence · High | Data Confidence · High |
Overview Development Signal | Development Signal · Established | Development Signal · Established |
Overview Approval status | FDA approved | FDA approved |
Positioning Key differentiator | Direct on-tumor + immunomodulatory effects | No manufacturing slot needed, so it can be started immediately in rapidly progressing myeloma. |
Positioning Known limitation | CD38 downregulation, high tumor burden, and impaired effector function after prior lines. | BCMA loss, soluble BCMA acting as a sink, and T-cell exhaustion. |
Positioning Development positioning | — | Class-defining BCMA engager; competes with Elrexfio and BCMA CAR-T. |
MoA Mechanism | Daratumumab binds CD38 on plasma cells and other immune cells, inducing direct apoptosis, Fc-mediated ADCC/CDC, and immunomodulatory effects including depletion of CD38+ regulatory cells and enhanced T-cell clonality. | Simultaneously engages BCMA on plasma cells and CD3 on T cells, forming an immune synapse that redirects polyclonal T cells to lyse BCMA+ myeloma cells independent of TCR specificity. |
MoA Biomarker | CD38 expression on clonal plasma cells (universal in MM). | BCMA expression, MRD negativity, serum free light chain response. |
PK/PD Half-life | 20 h | ~2–3 weeks at steady state |
PK/PD Species | Mouse, Human, M-protein, FLC, minimal residual disease, immunophenotypic CD38 saturation | Cynomolgus monkey, T-cell activation markers, cytokine profile, soluble BCMA |
PK/PD Animal (cat.) | Human, Mouse | Human, NHP |
PK/PD Experiment | pd | pharmacokinetic |
Toxicology Species | Cynomolgus monkey, Mouse, Human | Mouse |
Toxicology Animal (cat.) | NHP | — |
Toxicology Major finding | Infusion-related reactions (premedication required), cytopenias, and increased infection risk; subcutaneous formulation reduces IRR rate. | Boxed warning for CRS and neurologic toxicity including ICANS. Profound hypogammaglobulinemia and infection — including opportunistic infection — drive most late morbidity. |
Toxicology CRS | N/A | CRS ~72%, grade ≥3 ~0.6% |
Clinical Safety signal | Infusion-related reactions (premedication required), cytopenias, and increased infection risk; subcutaneous formulation reduces IRR rate. | Boxed warning for CRS and neurologic toxicity including ICANS. Profound hypogammaglobulinemia and infection — including opportunistic infection — drive most late morbidity. |
Clinical Selected reported efficacy | ORR 35.3% | ORR 63% |
Clinical Reported ORR | 35.3% | 63.0% |
Clinical Reported PFS | — | ~11.3 mo |
Clinical Result source | ClinicalTrials.gov NCT02990338 | MajesTEC-1 (NCT03145181 / NCT04557098) |
Clinical Program phase | APPROVED | APPROVED |
Clinical Trial activity | No active/completed counts | No active/completed counts |
Clinical Trial ref | NCT02990338 | NCT03145181 |
타깃 · 모달리티 · 임상 근거 · 비임상 맥락으로 최대 5개 프로그램을 나란히 비교합니다. · 다음 갱신 D-5 · 마지막 9월 2일
현재 선택: 2개 · Data Tier에서 열림
프로그램 상세에서 관심 등록 후 2개 이상 모으면 여기서 한 번에 비교할 수 있습니다.
표가 넓으면 좌우로 스크롤하세요. 핵심 비교 모드에서는 중요 항목만 표시됩니다.
| 항목 | teclistamab (Tecvayli, JNJ-64007957, teclistamab-cqyv) Johnson & Johnson·BCMA × CD3 132 trials·t½ ~2–3 weeks at steady state | |
|---|---|---|
Overview Program | Darzalex (daratumumab) | Tecvayli (teclistamab) |
Overview Company | Janssen | Johnson & Johnson |
Overview Modality | ANTIBODY | ANTIBODY |
Overview Target | CD38 | BCMA × CD3 |
Overview Indication | Multiple myeloma | Relapsed or refractory multiple myeloma |
Overview Phase | APPROVED | APPROVED |
Overview Status | APPROVED | APPROVED |
Overview Content status | Curated Core | Curated Core |
Overview Data Confidence | Data Confidence · High | Data Confidence · High |
Overview Development Signal | Development Signal · Established | Development Signal · Established |
Overview Approval status | FDA approved | FDA approved |
Positioning Key differentiator | Direct on-tumor + immunomodulatory effects | No manufacturing slot needed, so it can be started immediately in rapidly progressing myeloma. |
Positioning Known limitation | CD38 downregulation, high tumor burden, and impaired effector function after prior lines. | BCMA loss, soluble BCMA acting as a sink, and T-cell exhaustion. |
Positioning Development positioning | — | Class-defining BCMA engager; competes with Elrexfio and BCMA CAR-T. |
MoA Mechanism | Daratumumab binds CD38 on plasma cells and other immune cells, inducing direct apoptosis, Fc-mediated ADCC/CDC, and immunomodulatory effects including depletion of CD38+ regulatory cells and enhanced T-cell clonality. | Simultaneously engages BCMA on plasma cells and CD3 on T cells, forming an immune synapse that redirects polyclonal T cells to lyse BCMA+ myeloma cells independent of TCR specificity. |
MoA Biomarker | CD38 expression on clonal plasma cells (universal in MM). | BCMA expression, MRD negativity, serum free light chain response. |
PK/PD Half-life | 20 h | ~2–3 weeks at steady state |
PK/PD Species | Mouse, Human, M-protein, FLC, minimal residual disease, immunophenotypic CD38 saturation | Cynomolgus monkey, T-cell activation markers, cytokine profile, soluble BCMA |
PK/PD Animal (cat.) | Human, Mouse | Human, NHP |
PK/PD Experiment | pd | pharmacokinetic |
Toxicology Species | Cynomolgus monkey, Mouse, Human | Mouse |
Toxicology Animal (cat.) | NHP | — |
Toxicology Major finding | Infusion-related reactions (premedication required), cytopenias, and increased infection risk; subcutaneous formulation reduces IRR rate. | Boxed warning for CRS and neurologic toxicity including ICANS. Profound hypogammaglobulinemia and infection — including opportunistic infection — drive most late morbidity. |
Toxicology CRS | N/A | CRS ~72%, grade ≥3 ~0.6% |
Clinical Safety signal | Infusion-related reactions (premedication required), cytopenias, and increased infection risk; subcutaneous formulation reduces IRR rate. | Boxed warning for CRS and neurologic toxicity including ICANS. Profound hypogammaglobulinemia and infection — including opportunistic infection — drive most late morbidity. |
Clinical Selected reported efficacy | ORR 35.3% | ORR 63% |
Clinical Reported ORR | 35.3% | 63.0% |
Clinical Reported PFS | — | ~11.3 mo |
Clinical Result source | ClinicalTrials.gov NCT02990338 | MajesTEC-1 (NCT03145181 / NCT04557098) |
Clinical Program phase | APPROVED | APPROVED |
Clinical Trial activity | No active/completed counts | No active/completed counts |
Clinical Trial ref | NCT02990338 | NCT03145181 |
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