Table 3.
CD47-targeting drugs in the clinical trial and investigational new drug (IND) stage (Please refer the separate excel).
| Company Name (sponsor) | Drug name | main component | Target | Disease | Clinical phase | Combination drug | single-drug therapy or combination therapy | National Clinical Traial Number (NCT NO.) |
|---|---|---|---|---|---|---|---|---|
| (a) CD47-targeting drugs in clinical trial (registered in US) and IND stage | ||||||||
| Akeso | AK117 | Monoclonal Antibody | CD47 | MDS | Phase 1/2 | Azacitidine | combination therapy | NCT04900350 |
| AML | Phase 1/2 | Azacitidine | combination therapy | NCT04980885 | ||||
| Advanced Malignancies | Phase 1/2 | AK112/Chemotherapy | combination therapy | NCT05214482 | ||||
| Advanced Malignancies | Phase 1/2 | AK112/Carboplatin/Cisplatin/5-Fluorouracil | combination therapy | NCT05229497 | ||||
| Advanced Malignancies | Phase 1/2 | AK104/Capecitabine tablets/Oxaliplatin/Cisplatin/Paclitaxel/Irinotecan/Docetaxel/5-FU | combination therapy | NCT05235542 | ||||
| Neoplasms Malignant | Phase 1 | single-drug therapy |
NCT04728334/ NCT04349969 |
|||||
| ALX Oncology | ALX148/evorpacept | Fusion protein | CD47 | Gastric Cancer | Phase 2/3 | Trastuzumab/Ramucirumab/Paclitaxel | combination therapy | NCT05002127 |
| NHL | Phase 1/2 | Lenalidomide/Biological: Rituximab | combination therapy | NCT05025800 | ||||
| MDS | Phase 1/2 | Azacitidine | combination therapy | NCT04417517 | ||||
| AML | Phase 1/2 | Venetoclax/Drug: Azacitidine | combination therapy | NCT04755244 | ||||
| Head and Neck Cancer | Phase 2 | Pembrolizumab/Cisplatin/Carboplatin; 5FU | combination therapy | NCT04675333 | ||||
| Head and Neck Cancer | Phase 2 | Pembrolizumab | combination therapy | NCT04675294 | ||||
| MSS Metastatic Colorectal Cancer | Phase 2 | Cetuximab/Drug: Pembrolizumab | combination therapy | NCT05167409 | ||||
| Solid Tumor/NHL | Phase 1 | Pembrolizumab/Trastuzumab/Rituximab/Ramucirumab + Paclitaxel/5-FU + Cisplatin | combination therapy | NCT03013218 | ||||
| Arch Oncology | AO-176 | Monoclonal Antibody | CD47 | Solid Tumor | Phase 1/2 | Paclitaxel/Pembrolizumab | combination therapy | NCT03834948 |
| Multiple Myeloma | Phase 1/2 | Dex/Dex + Bort | combination therapy | NCT04445701 | ||||
| Bio-Thera Solutions | BAT7104 | bispecific antibody | CD47/PD-L1 | Solid Tumor | Phase 1 | single-drug therapy | NCT05200013 | |
| Chia Tai Tianqing | TQB2928 | Monoclonal Antibody | CD47 | Advanced Malignancies | Phase 1 | single-drug therapy | NCT05192512 | |
| Elpiscience | ES004 | Monoclonal antibody | SIRPα | Malignant tumor | IND | / | ||
| EpicentRx | RRx-001 | Small molecular | CD47/SIRPα axis | Small Cell Lung Cancer | Phase 3 | Cisplatin/carboplatin plus etoposide | combination therapy | NCT03699956 |
| Colorectal Neoplasms | Phase 2 | Regorafenib/Irinotecan | combination therapy | NCT02096354 | ||||
| Solid Tumor | Phase 2 | Cisplatin/Cisplatin/Etoposide/Carboplatin/Irinotecan/Vinorelbine/Doxil/Gemcitabine/Taxane/Paclitaxel/ Nab-Paclitaxel/Pemetrexed | combination therapy | NCT02489903 | ||||
| Oral Mucositis | Phase 2 | Cisplatin | combination therapy | NCT03515538 | ||||
| Cholangiocarcinoma | Phase 2 | Gemcitabine and cisplatin | combination therapy | NCT02452970; erminated (Resensitization or clinical benefit was not observed) | ||||
| Brain Metastases | Phase 1 | WBRT | combination therapy | NCT02215512 | ||||
| Solid Tumor/Lymphoma | Phase 1 | single-drug therapy | NCT02096341 | |||||
| Progressive Malignant Solid and Central Nervous System Tumors (PIRATE) | Phase 1 | Temozolomide/ Irinotecan | combination therapy | NCT04525014 | ||||
| Metastatic or Advanced Cancer | Phase 1 | Irinotecan | combination therapy | NCT02801097 | ||||
| Solid Tumor/Lymphoma | Phase 1 | Nivolumab | combination therapy | NCT02518958 | ||||
| Glioblastoma and Anaplastic Gliomas | Phase 1 | Temozolomide/TMZ | combination therapy | NCT02871843 | ||||
| Solid Tumor/Lymphoma | Phase 1 | single-drug therapy | NCT01359982 | |||||
| Conjupro | CPO107 | bispecific antibody | SIRPα/CD20 | CD20 Positive NHL | Phase 1/2 | single-drug therapy | NCT04853329 | |
| GeneScience | Gentulizumab | Monoclonal Antibody | CD47 | Solid Tumor/NHL | Phase 1 | single-drug therapy | NCT05221385 | |
| CD47 | AML/MDS | Phase 1 | single-drug therapy | NCT05263271 | ||||
| Gilead Sciences | Magrolimab | Monoclonal Antibody | CD47 | HL | Phase 2 | Drug: Pembrolizumab/Procedure: PET/CT | combination therapy | NCT04788043 |
| MDS/AML | Phase 1/2 | Drug: Sabatolimab/Drug: Azacitidine | combination therapy | NCT05367401 | ||||
| Solid Tumor | Phase 1 | single-drug therapy | NCT02216409 | |||||
| Hematological Malignancies | Phase 1 | Drug: Azacitidine | combination therapy | NCT03248479 | ||||
| Lymphoma | Phase 1 | Drug: Obinutuzumab/Drug: Venetoclax | combination therapy | NCT04599634 | ||||
| Hengrui Pharmaceuticals | SHR-1603 | Monoclonal Antibody | CD47 | Nasopharyngeal Carcinoma | Phase1 | single and combined withGemcitabine/Cisplatin/Albumin Paclitaxel | single-drug therapy and combination therapy | NCT04282070 |
| Solid Tumor | Phase 1 | single-drug therapy | NCT03710265 | |||||
| I-MAB | TJC4 | monoclonal antibody | CD47 | AML/MDS | Phase1 | Lemzoparlimab/Azacitidine/Venetoclax | combination therapy | NCT04912063 |
| Multiple Myeloma | Phase1 | Lemzoparlimab/Dexamethasone/Carfilzomib/Pomalidomide/Daratumumab | combination therapy | NCT04895410 | ||||
| TJ-011133 (Lemzoparlimab) | Solid Tumor | Phase 1/2 | toripalimab | combination therapy | NCT05148533 | |||
| AML/MDS | Phase 1/2 | single-drug therapy | NCT04202003 | |||||
| MDS | Phase 1 | Azacitidine/Venetoclax | combination therapy | NCT04912063 | ||||
| Multiple Myeloma | Phase 1 | Single or combined with examethasone/Carfilzomib/Pomalidomide/Daratumumab | single-drug therapy and combination therapy | NCT04895410 | ||||
| Solid Tumor/Lymphoma | Phase 1 | Pembrolizumab/Rituximab | combination therapy | NCT03934814 | ||||
| MDS | Phase 1 | Azacitidine/Venetoclax | combination therapy | NCT04912063 | ||||
| ImmuneOncia | IMC-002 | Monoclonal Antibody | CD47 | Advanced Malignancies | Phase 1 | single-drug therapy | NCT05276310/NCT04306224 | |
| ImmuneOnco Biopharma | IMM-01 | Fusion protein | CD47 | AML/MDS | Phase 1/2 | Azacitidine | combination therapy | NCT05140811 |
| IMM-2505 | bispecific antibody | PD-L1/CD47 | Advanced Malignancies | IND | single-drug therapy | IND | ||
| IMM2902 | bispecific antibody | CD47/SIRPα | HER2-expressing Advanced Solid Tumor | Phase 1 | single-drug therapy | NCT05076591 | ||
| IMM0306 | bispecific antibody | CD47/CD20 | B-NHL | Phase 1 | single-drug therapy | NCT04746131 | ||
| Innovent | SG2501 | bispecific antibody | CD38/CD47 | Hematological Malignancy | Phase 1 | single-drug therapy | NCT05293912 | |
| IBI397 | Monoclonal Antibody | SIRPα | IND | IND | ||||
| IBI188 | Monoclonal Antibody | CD47 | Advanced Malignancies | Phase 1 | single-drug therapy | NCT03763149/NCT03717103 | ||
| IBI322 | bispecific antibody | CD47/PDL1 | Advanced Malignancies | Phase 1 | single-drug therapy | NCT04338659/NCT04328831 | ||
| Solid Tumor | Phase 1 | single-drug therapy | NCT04912466 | |||||
| Hematological Malignancy | Phase 1 | single-drug therapy | NCT04795128 | |||||
| Myeloid Tumor | Phase 1 | HMA | combination therapy | NCT05148442 | ||||
| Company Name (sponsor) | Drug name | main component | Target | Disease | Clinical phase | Combination drug | single-drug therapy or combination therapy |
National Clinical Traial Number (NCT NO.) |
| JMT BIO | JMT601 | Fusion protein | CD20/CD47 | NHL | Phase 1/2 | single-drug therapy | NCT04853329 | |
| Advanced Malignancies | Phase 1 | single-drug therapy |
NCT03722186； Suspended (Business Decision) |
|||||
| KAHR Medical | DSP107 | bispecific antibody | CD47/41BB | NSCLC | Phase1/2 | Atezolizumab | single-drug therapy and combination therapy | NCT04440735 |
| Hematological Malignancies | Phase1 | Azacitidine/Venetoclax | single-drug therapy and combination therapy | NCT04937166 | ||||
| Lunan Pharmacy | Monoclonal antibody | CD47 | Malignant tumor | IND | single-drug therapy | / | ||
| MABWELL | 6MW3211 | Bispecific antibody | CD47/PD-L1 | Advanced Malignant Neoplasm | Phase1/2 | single-drug therapy | NCT05048160 | |
| MAB WORKS | MIL-95 | Monoclonal antibody | CD47 | Advanced Malignancies | Phase 1 | single-drug therapy | NCT04651348 | |
| OSE Immunotherapeutics | OSE-172 | Monoclonal antibody | SIRPα | Solid Tumor | Phase1 | BI 754091 | single-drug therapy and combination therapy | NCT03990233 |
| Advanced Cancer | Phase 1 | ezabenlimab/[89Zr]Zr- BI 765063 | combination therapy | NCT05068102 | ||||
| HNSCC | Phase1 | Ezabenlimab/BI 836880/Cetuximab/Investigatoŕs Choice Chemotherapy | combination therapy | NCT05249426 | ||||
| Solid Tumor | Phase1 | BI 754091 | single-drug therapy and combination therapy | NCT04653142 | ||||
| Pfizer | PF-07257876 | bispecific antibody | CD47/PDL1 | Solid Tumor | Phase 1 | single-drug therapy | NCT04881045 | |
| Seagen | SGN-CD47M | Antibody–Drug Conjugates | CD47 | Solid Tumor | Phase 1 | single-drug therapy | NCT03957096 | |
| Shattuck Labs | SL-172154 | bispecific antibody | SIRPα/CD40L | SCC | Phase 1 | single-drug therapy | NCT04502888 | |
| Sorrento Therapeutics | STI-6643 | Monoclonal Antibody | CD47 | Solid Tumor | Phase 1 | single-drug therapy | NCT04900519 | |
| SUNHO（China） | IBC0966 | bispecific antibody | CD47/PDL1 | Advanced Malignancies | Phase 1/2 | single-drug therapy | NCT04980690 | |
| Surface Oncology | SRF231628,629 | Monoclonal Antibody | CD47 | Solid Tumor/Hematological Malignancy | Phase1 | single-drug therapy | NCT03512340 | |
| SUMGEN | SG12473 | bispecific antibody | CD47/PD-1 | Malignant tumor | Phase 1 | single-drug therapy | CTR20211029 | |
| SG2501 | bispecific antibody | CD47/CD38 | Hematological Malignancy | Phase 1 | single-drug therapy | NCT05293912 | ||
| SG404 | Fusion protein | CD47 | Malignant tumor | Phase 1 | single-drug therapy | CTR20202489 | ||
| TG Therapeutics | TG-1801 | bispecific antibody | CD47/CD19 | Hematological Malignancy | Phase 1 | Biological: Ublituximab | combination therapy | NCT04806035 |
| Trillium | TTI-622 | Fusion protein | CD47 | Solid Tumor | Phase 1/2 | Pegylated Liposomal Doxorubicin | combination therapy | NCT05261490 |
| Leiomyosarcoma | Phase 1/2 | Doxorubicin | combination therapy | NCT04996004 | ||||
| Multiple Myeloma | Phase 1 | Daratumumab Hyaluronidase-fihj | combination therapy | NCT05139225 | ||||
| Hematological Malignancy | Phase 1 | Azacitidine/Venetoclax/Carfilzomib/Dexamethasone/anti-CD20 targeting agent | single-drug therapy and combination therapy | NCT03530683 | ||||
| Solid Tumor | Phase 1 | Monotherapy/Drug: PD-1/PD-L1 Inhibitor/pegylated interferon-α2a/Other:T-Vec/Other: radiation | combination therapy | NCT02890368 | ||||
| Advanced Malignancies | Phase 1 | Drug: Rituximab/Drug: Nivolumab | combination therapy | NCT02663518 | ||||
| Trillium Therapeutics | TT1-621 | Fusion protein | CD47 | Leiomyosarcoma | Phase 1/2 | Doxorubicin | combination therapy | NCT04996004 |
| Solid Tumor/Hematological Malignancy | Phase1 | Rituximab/Drug: Nivolumab | single-drug therapy and combination therapy | NCT02663518 | ||||
| Solid Tumor | Phase1 | PD-1/PD-L1 Inhibitor/pegylated interferon-α2a/T-Vec/radiation | single-drug therapy and combination therapy | NCT02890368 | ||||
| Waterstone | HX009 | bispecific antibody | CD47/PD1 | Lymphoma | Phase 2 | single-drug therapy | NCT05189093 | |
| Solid Tumor | Phase 1/2 | single-drug therapy | NCT04886271/NCT04097769 | |||||
| ZAI LAB | ZL-1201 | Monoclonal Antibody | CD47 | Advanced Cancer | Phase 1 | single-drug therapy | NCT04257617 | |
| Celgene Corporation | Anti-SIRPα | CC-95251 | SIRPα | Advanced Solid and Hematologic Cancers | Phase1 | Cetuximab, Rituximab | Alone and in Combination with Cetuximab or Rituximab |
NCT03783403 |
| Celgene | CC-90002 | Monoclonal Antibody | CD47 | AML/MDS | Phase1 | single-drug therapy | NCT02641002 | |
| Insilico Medicine | ISM004-1057D | targeting pyroglutamylation of CD47 | CD47（isoQC） | Solid Tumor/Hematological Malignancy | IND | IND | ||
| Nantes University Hospital | Monoclonal Antibody | SIRPα | HCC | Phase 1 | single-drug therapy |
NCT02868255 completed in Sep.2021 |
||
| Gilead Sciences(Bought Forty Seven in 2020) | Magrolimab (Hu5F9 G4) | Monoclonal Antibody | CD47 | Myelodysplastic Syndromes | Phase 3 | Azacitidine/Placebo | combination therapy | NCT04313881 |
| AML | Phase 3 | Venetoclax/Azacitidine | combination therapy | NCT05079230 | ||||
| AML | Phase 3 | Azacitidine | combination therapy | NCT04778397 | ||||
| Hodgkin Lymphoma | Phase 2 | Pembrolizumab | combination therapy | NCT04788043 | ||||
| Solid Tumors | Phase 2 | Docetaxel | combination therapy | NCT04827576 | ||||
| Metastatic Colorectal Cancer | Phase 2 | Bevacizumab/Irinotecan/Fluorouracil/Leucovorin | combination therapy | NCT05330429 | ||||
| Triple-Negative Breast Cancer | Phase 2 | Nab-Paclitaxel/Paclitaxel/Sacituzumab govitecan | combination therapy | NCT04958785 | ||||
| Multiple Myeloma | Phase 2 | Daratumumab/Pomalidomide/Dexamethasone/Bortezomib/Carfilzomib | combination therapy | NCT04892446 | ||||
| Head and Neck Squamous Cell Carcinoma | Phase 2 | pembrolizumab/5-FU/platinum/docetaxel | combination therapy | NCT04854499 | ||||
| Myeloid Malignancies | Phase 2 | venetoclax/azacitidine /mitoxantrone/etoposide/cytarabine/CC-486 | combination therapy | NCT04778410 | ||||
| Solid Tumor | Phase 1/2 | Cetuximab | combination therapy |
NCT02953782 finished in Mar.2021 |
||||
| Non Hodgkin Lymphoma | Phase 1/2 | rituximab/gemcitabine/oxaliplatin | combination therapy | NCT02953509 | ||||
| AML | Phase 1/2 | Azacitidine/Venetoclax | combination therapy | NCT04435691 | ||||
| Urothelial Carcinoma | Phase 1/2 | Atezolizumab | combination therapy | NCT03869190 | ||||
| MDS/AML | Phase 1/2 | Sabatolimab/Azacitidine | combination therapy | NCT05367401 | ||||
| T-Cell Lymphoma | Phase 1/2 | mogamulizumab | combination therapy | NCT04541017；Suspended (Other - Amendment Request) | ||||
| B-cell Malignancies | Phase 1 | Obinutuzumab/Venetoclax | combination therapy | NCT04599634 | ||||
| Hematological Malignancies | Phase 1 | Azacitidine | combination therapy | NCT03248479 | ||||
| AML | Phase 1 | Atezolizumab | combination therapy | NCT03922477 | ||||
| Ovarian Cancer | Phase 1 | Avelumab | combination therapy |
NCT03558139 Completed in Dec.2020 |
||||
| Non-Hodgkin's Lymphoma | Phase 1 | Acalabrutinib/AZD6738/Rituximab/AZD5153 | combination therapy | NCT03527147 | ||||
| Neuroblastoma/Osteosarcoma | Phase 1 | Dinutuximab/ | combination therapy | NCT04751383 | ||||
| MDS/AML | Phase 1 | single-drug therapy | NCT02678338 | |||||
| Solid Tumor | Phase 1 | single-drug therapy | NCT02216409 | |||||
| Brain Tumors | Phase 1 | single-drug therapy | NCT05169944 | |||||
| Shandong New Time Pharmaceutical | F527 | Monoclonal Antibody | CD47 | Lymphoma | Phase 1 | single-drug therapy | NCT05293028 | |
| (b) CD47-targeting drugs in clinical trial (registered in China) and IND stage | ||||||||
| 3D Medicines/ImmuneOncia Therapeutics | 3D-197/IMC-002 | Monoclonal Antibody | CD47 | Solid Tumor/Lymphoma | Phase 1 | single-drug therapy | CTR20220544 | |
| Akeso | AK117 | Monoclonal Antibody | CD47 | Advanced Malignancies | Phase 1/2 | AK112 | combination therapy | CTR20220121 |
| Advanced Malignancies | Phase 1/2 | AK112 | combination therapy | CTR20212989 | ||||
| Advanced Malignancies | Phase 1/2 | AK104 | combination therapy | CTR20220284 | ||||
| BioRay | BR105 | Monoclonal Antibody | SIRPα | Advanced Malignancies | Phase 1 | single-drug therapy | CTR20220467 | |
| Bio-Thera Solutions | BAT7104 | bispecific antibody | CD47/PDL1 | Advanced Malignancies | Phase 1 | single-drug therapy | CTR20220098 | |
| Chia Tai Tianqing | TQB2928 | Monoclonal Antibody | CD47 | Advanced Malignancies | Phase 1 | single-drug therapy | CTR20213324 | |
| GeneScience | gentulizumab | Monoclonal Antibody | CD47 | Hematological Malignancy | Phase 1 | single-drug therapy | CTR20210066 | |
| Hengrui Pharmaceutical | SHR-1603 | Monoclonal Antibody | CD47 | Advanced Malignancies | Phase 1 | not declared publically | CTR20181964,stopped | |
| ImmuneOnco Biopharma | IMM01 | Fusion protein | CD47 | Lymphoma | Phase 1 | not declared publically | CTR20191531 | |
| HL/B-NHL/AML/MDS/MM | Phase 2 | single-drug therapy | CTR20212227 | |||||
| AML/MDS | Phase 1 | Azacitidine | combination therapy | CTR20212519 | ||||
| Solid Tumor | Phase 1/2 | BGB-A317 | combination therapy | CTR20220791 | ||||
| IMM0306 | bispecific antibody | CD47/CD20 | NHL | Phase 1 | not declared publically | CTR20192612 | ||
| IMM2902 | bispecific antibody | CD47/SIRPα | Solid Tumor | Phase 1 | single-drug therapy | CTR20212375 | ||
| Innovent | IBI188/Letaplimab | Monoclonal Antibody | CD47 | Advanced Malignancies | Phase 1 | single-drug therapy | CTR20210761 | |
| Advanced Malignancies | Phase 1 | not declared publically | CTR20182140 | |||||
| AML | Phase 1/2 | Azacitidine/Decitabine | single-drug therapy and combination therapy | CTR20200938 | ||||
| MDS | Phase 1/3 | Azacitidine | combination therapy | CTR20201039 | ||||
| IBI322 | bispecific antibody | CD47/PDL1 | Advanced Malignancies | Phase 1 | Bevacizumab/Docetaxel | single-drug therapy and combination therapy | CTR20200175 | |
| Solid Tumor | Phase 1 | Sintilimab/Bevacizumab | single-drug therapy and combination therapy | CTR20211251 | ||||
| Hematological Malignancy | Phase 1 | single-drug therapy | CTR20210385 | |||||
| Myeloid Malignancies | Phase 1 | single-drug therapy | CTR20213120 | |||||
| IBI397 | Advanced Malignancies | Phase 1 | single-drug therapy | CTR20220193 | ||||
| ZL-1201 | Monoclonal Antibody | CD47 | Solid Tumor or Hematological Malignancy | Phase 1 | single-drug therapy | CTR20210973 | ||
| JMT BIO | JMT601 | Fusion protein | CD20/CD47 | NHL | Phase 1 | single-drug therapy | CTR20211365 | |
| Mabwell | 6MW3211 | bispecific antibody | CD47/PDL1 | Advanced Malignancies | Phase 1/2 | single-drug therapy | CTR20211936 | |
| SUMGEN | SG12473 | bispecific antibody | CD47/PDL1 | Advanced Malignancies | Phase 1 | single-drug therapy | CTR20211029 | |
| SG404 | Fusion protein | CD47 | Advanced Malignancies | Phase 1 | single-drug therapy | CTR20202489 | ||
| SUNHO（China） | IBC0966 | bispecific antibody | CD47/PDL1 | Advanced Malignancies | Phase 1/2 | single-drug therapy | CTR20211609 | |
| Waterstone | HX009 | bispecific antibody | Solid Tumor | Phase 2 | single-drug therapy | CTR20211292 | ||
| CD47/PD1 | Solid Tumor | Phase 1 | not declared publically | CTR20192299 | ||||
| Lymphoma | Phase 1/2 | single-drug therapy | CTR20213391 | |||||
| Shandong New Time Pharmaceutical | F527 | Monoclonal Antibody | CD47 | Lymphoma | Phase 1 | single-drug therapy | CTR20220738 | |
| MAB WORKS | MIL95 | Monoclonal Antibody | CD47 | Solid Tumor or Hematological Malignancy | Phase 1 | single-drug therapy | CTR20201108 | |