Table 1.
Registered Clinical Trials of Drugs Blocking CD47-SIRPα Axis in the NCT and CDT System.
| Agent | CD47 Isotype | Mechanism | Condition or Disease | Phase | Enrollment | Start Date | Status | Preliminary clinical data reported (Ref.) |
|---|---|---|---|---|---|---|---|---|
| B6H12.2 | IgG4 | Humanized anti-CD47 mAb | Advanced Malignancies (include ovarian cancer) | Cell lines animal mode | NA | NA | NA | 43,46,75,87–89 |
| Hu5F9-G4 (Magrolimab) | IgG4 | Humanized anti-CD47 mAb | Solid Tumor (includes fallopian tube and ovarian cancers) | 1 | 88 | 2014-08 | Completed | 89, NCT0221640990 |
| AML/MDS | 1 | 20 | 2015-12 | Completed | NCT0267833891 | |||
| Solid Tumor | 1 | 78 | 2016-12-01 | Completed | NCT02953782 | |||
| NHL | 1 | 178 | 2016-12-21 | Active, not recruiting | NCT02953509 | |||
| Hematological Malignancies | 1 | 258 | 2017-09-08 | Active, not recruiting | NCT02678338 | |||
| Hematological Malignancies | 1 | 258 | 2017-09-08 | Active, not recruiting | NCT03248479 | |||
| OC | 1 | 34 | 2018-05-23 | Completed | NCT03558139 | |||
| NHL/DLBCL | 1 | 30 | 2018-06-19 | Completed | NCT03527147 | |||
| Urothelial Carcinoma | 1b/2 | 645 | 2019-06-01 | Recruiting | NCT03869190 | |||
| AML | 1 | 13 | 2019-10-08 | Terminated | NCT03922477 | |||
| Solid Tumor | 1 | 7 | 2020-07-28 | Completed | NCT04403308 | |||
| AML | 1/2 | 98 | 2020-07-28 | Recruiting | NCT04435691 | |||
| MDS | 3 | 520 | 2020-09-09 | Recruiting | NCT04313881 | |||
| T-cell Lymphoma | 1b/2 | 18 | 2020-12-24 | Suspended | NCT04541017 | |||
| Neuroblastoma/Osteosarcoma | 1 | 82 | 2021-04-16 | Recruiting | NCT04751383 | |||
| AML | 3 | 346 | 2021-06-01 | Recruiting | NCT04778397 | |||
| MM | 2 | 128 | 2021-06-28 | Recruiting | NCT04778410 | |||
| Head and Neck Squamous Cell Carcinoma | 2 | 230 | 2021-09-07 | Recruiting | NCT04854499 | |||
| Solid Tumor | 2 | 116 | 2021-10-01 | Recruiting | NCT04827576 | |||
| MM | 2 | 153 | 2021-12-09 | Recruiting | NCT04892446 | |||
| Triple-Negative Breast Cancer | 2 | 144 | 2021-12-14 | Recruiting | NCT04958785 | |||
| B-cell Malignancies | 1 | 76 | 2021-12-16 | Recruiting | NCT04599634 | |||
| HL | 2 | 24 | 2022-06-21 | Recruiting | NCT04788043 | |||
| AML | 3 | 432 | 2022-07-07 | Recruiting | NCT05079230 | |||
| CC-90002 | IgG4 | Humanized anti-CD47 mAb | Hematologic Neoplasms | 1 | 60 | 2015-03-12 | Completed | 92, NCT02367196 |
| Hematologic Neoplasms | 1 | 28 | 2016-03-01 | Terminated | NCT02641002 | |||
| TTI-621 | IgG1 | SIRPα-IgG1 Fc Fusion Protein | Hematologic Malignancies/Solid Tumor | 1 | 250 | 2016-01-31 | Active, not recruiting | 93,94, NCT0266351895,96 |
| Solid Tumor/Mycosis Fungoides | 1 | 56 | 2016-09 | Terminated | 97, NCT0289036898 | |||
| Leiomyosarcoma | 2 | 80 | 2021-06-22 | Recruiting | NCT04996004 | |||
| MM | 1 | 32 | 2021-10-28 | Recruiting | NCT05139225 | |||
| TTI-622 | IgG4 | SIRPα-IgG4 Fc Fusion Protein | Hematological Malignancies | 1 | 386 | 2018-07-07 | Recruiting | 99, NCT03530683 |
| MM | 1 | 32 | 2021-10-28 | Recruiting | NCT05139225 | |||
| OC | 1/2 | 50 | 2022-02-14 | Recruiting | NCT05261490 | |||
| ALX148 (Evorpacept) | IgG4 | Humanized anti-CD47 mAb | Solid Tumor/NHL | 1 | 174 | 2017-02-03 | Active, not recruiting | 100, NCT03013218101 |
| Higher Risk MDS | 1/2 | 173 | 2020-10-02 | Recruiting | NCT04417517 | |||
| Head and Neck Cancer | 2 | 183 | 2021-04-02 | Recruiting | NCT04675294 | |||
| AML | 1/2 | 97 | 2021-05-05 | Active, not recruiting | NCT04755244 | |||
| Head and Neck Cancer | 2 | 168 | 2021-05-10 | Recruiting | NCT04675333 | |||
| HER2+ Cancers | 1/2 | 93 | 2021-09-15 | Recruiting | NCT05027139 | |||
| B-cell NHL | 1/2 | 52 | 2021-10-13 | Recruiting | NCT05025800 | |||
| Gastric Cancer | 2/3 | 450 | 2022-01-15 | Recruiting | NCT05002127 | |||
| Ti-061 | IgG4 | Humanized anti-CD47 mAb | Advanced Malignancies | 1 | 160 | 2017-04-05 | Terminated | EudraCT number, 2016-004372-22102 |
| SRF231 | IgG4 | Humanized anti-CD47 mAb | Advanced Solid/Hematologic Cancers | 1 | 148 | 2018-03-13 | Completed | 103, NCT03512340104 |
| SHR-1603 | IgG4 | Humanized anti-CD47 mAb | Advanced Malignancies | 1 | 128 | 2018-12-13 | Suspended | 105, NCT03722186 |
| IBI188 | IgG4 | Humanized anti-CD47 mAb | Advanced Malignancies | 1 | 49 | 2019-01-10 | Completed | NCT03717103 |
| Advanced Malignancies | 1 | 20 | 2019-01-19 | Completed | NCT03763149 | |||
| MDS | 1 | 32 | 2020-08-24 | Suspended | NCT04511975 | |||
| AML | 1/2 | 126 | 2020-09-25 | Unknown | 106, NCT04485052 | |||
| MDS | 1 | 12 | 2020-09-30 | Recruiting | NCT04485065 | |||
| Solid Tumor | 1 | 120 | 2021-05-25 | Recruiting | NCT04861948 | |||
| IBI322 | IgG4 | Humanized anti-CD47/PD-L1 BsAb | Advanced Malignancies | 1 | 218 | 2020-07-31 | Recruiting | 107, NCT04328831 |
| Advanced Lymphomas | 1 | 51 | 2021-01-14 | Recruiting | NCT04338659 | |||
| Hematologic Malignancy | 1 | 230 | 2021-05-07 | Recruiting | NCT04795128 | |||
| Advanced Solid Tumor | 1 | 36 | 2021-06-20 | Recruiting | NCT04912466 | |||
| Myeloid Tumor | 1 | 124 | 2021-12-31 | Not yet recruiting | NCT05148442 | |||
| NSCLC | 2 | 80 | 2022-07-20 | Not yet recruiting | NCT05296278 | |||
| SCLC | 2 | 40 | 2022-07-22 | Not yet recruiting | NCT05296603 | |||
| AO-176 | IgG2 | Humanized anti-CD47 mAb | Solid Tumor (includes epithelial ovarian carcinoma) | 1/2 | 183 | 2019-02-04 | Active, not recruiting | 108,109, NCT03834948110 |
| MM | 1/2 | 157 | 2020-12-30 | Active, not recruiting | NCT04445701 | |||
| TG-1801 | IgG4 | Humanized anti- CD47/CD19 BsAb | B-Cell Lymphoma | 1 | 16 | 2019-03-05 | Recruiting | NCT03804996 |
| B-Cell Lymphoma/CLL | 1 | 60 | 2021-04-23 | Recruiting | NCT04806035 | |||
| TJ4 (TJ011133) | IgG4 | Humanized anti-CD47 mAb | Solid Tumor/Lymphoma | 1 | 98 | 2019-04-16 | Active, not recruiting | 111, NCT03934814112 |
| AML/MDS | 1/2 | 100 | 2020-03-25 | Recruiting | NCT04202003113 | |||
| AML/MDS | 1 | 38 | 2021-06-25 | Active, not recruiting | NCT04912063 | |||
| Advanced Solid Tumor | 1/2 | 96 | 2021-12-30 | Recruiting | NCT05148533 | |||
| MM | 1 | 8 | 2022-01-17 | Terminated | NCT04895410 | |||
| BI 765063 (OSE-172) | IgG4 | Humanized against SIRPα mAb | Solid Tumor | 1 | 116 | 2019-4-16 | Recruiting | NCT03990233 |
| Solid Tumor | 1 | 18 | 2020-12-15 | Completed | NCT04653142 | |||
| HX009 | IgG4 | Humanized anti- CD47/PD-1 BsAb | Advanced Solid Tumor | 1 | 21 | 2019-06-12 | Active, not recruiting | NCT04097769 |
| Advanced Solid Tumor | 2 | 210 | 2021-05-12 | Active, not recruiting | NCT04886271 | |||
| Relapsed/Refractory Lymphoma | 1/2 | 99 | 2021-12-31 | Recruiting | NCT05189093 | |||
| IMM01 | IgG1 | SIRPα-IgG1 Fc Fusion Protein | Relapsed/Refractory Lymphoma | 1 | 30 | 2019-09-09 | Recruiting | CTR20191531114 |
| AML/MDS | 1/2 | 76 | 2022-01-01 | Not yet recruiting | NCT05140811 | |||
| AK117 | IgG4 | Humanized anti-CD47 mAb | Neoplasms Malignant | 1 | 159 | 2020-04-25 | Active, not recruiting | NCT04349969115 |
| Neoplasms Malignant | 1 | 162 | 2021-01-27 | Recruiting | NCT04728334 | |||
| MDS | 1/2 | 190 | 2021-06-18 | Recruiting | NCT04900350 | |||
| AML | 1/2 | 160 | 2021-07 | Recruiting | NCT04980885 | |||
| Triple-negative Breast Cancer | 2 | 80 | 2022-03-23 | Recruiting | NCT05227664 | |||
| Advanced Malignant Tumors | 1/2 | 114 | 2022-05-04 | Recruiting | NCT05229497 | |||
| Advanced Malignant Tumors | 1/2 | 130 | 2022-07-12 | Recruiting | NCT05235542 | |||
| Metastatic Colorectal Cancer | 2 | 114 | 2022-07-27 | Recruiting | NCT05382442 | |||
| ZL-1201 | IgG4 | Humanized anti-CD47 mAb | Advanced Cancer | 1 | 37 | 2020-05-11 | Active, not recruiting | NCT04257617 |
| IMC-002 | IgG4 | Humanized anti-CD47 mAb | Solid Tumor/Lymphoma | 1 | 24 | 2020-06-05 | Recruiting | NCT04306224 |
| Advanced Cancer | 1 | 24 | 2022-05-10 | Recruiting | NCT05276310 | |||
| SL-172154 | IgG4 | Bispecific SIRPα-Fc-CD40L Fusion Protein | OC | 1 | 40 | 2020-07-29 | Recruiting | NCT04406623116 |
| DSP107 | IgG4 | Humanized anti- CD47/4-1BB BsAb | Advanced Solid Tumor | 1/2 | 100 | 2020-10-07 | Recruiting | 117, NCT04440735 |
| Hematological Malignancies | 1 | 36 | 2022-01-31 | Recruiting | NCT04937166 | |||
| SHR2150 | IgG4 | Selective TLR7 Agonist | Solid Tumor | 1/2 | 50 | 2020-10-10 | Recruiting | 118, NCT04588324 |
| IMM0306 | IgG1 | Humanized anti- CD47/CD20 BsAb | B-cell NHL | 1 | 90 | 2021-01-15 | Recruiting | 119, NCT04746131 |
| PF-07257876 | IgG4 | Humanized anti-CD47/PD-L1 BsAb | Selected Advanced Tumors (include OC) | 1 | 90 | 2021-08-15 | Recruiting | 120, NCT04881045 |
| STI-6643 | IgG4 | Humanized anti-CD47 mAb | Advanced Solid Tumor | 1 | 24 | 2021-12-21 | Recruiting | NCT04900519 |
Abbreviations: AML, acute myeloid leukemia; CLL, chronic lymphatic leukemia; DLBCL, diffuse large B cell lymphoma; HL, Hodgkin's lymphoma; MDS, myelodysplastic syndromes; MM, multiple myeloma; NA, not available; NHL, non-Hodgkin’s lymphoma; NSCLC, non-small cell lung carcinoma; SCLC, small cell lung carcinoma; TLR7, Toll-like receptor 7.
The related references cited in Table 1 can be found in Anonymous Main Document. Some important ICIs in the table are written in bold.