Table 3.
Clinical trials targeting LILRB family in hematological malignancies and solid tumors.
| Target | Agent | Drug type | Disease indication | Therapy | Intervention | Trial number | Phase and status | Trial duration |
|---|---|---|---|---|---|---|---|---|
| Hematological malignancies | ||||||||
| LILRB4 | IO-202 | IgG1 mAb | M-AML, CMML | Monotherapy and combination therapy | IO-202 alone; IO-202 and azacitidine (chemotherapy); IO-202 and azacitidine (chemotherapy) + venetoclax (BCL-2 inhibitor) |
NCT04372433 | Phase I (Completed) | Sep 2020 - Jan 2025 |
| LILRB4 CAR T | CAR T (Specific effector T-cells) | AML (M4/M5) | Monotherapy | Anti-LILRB4 CAR T cells | NCT04803929 | Phase I (Recruiting) | Mar 2021 - Mar 2026 | |
| LILRB4 STAR‑T | STAR-T (Specific effector T-cells) | AML | Monotherapy | LILRB4 STAR-T cells | NCT05518357 | Phase I (Completed) | Jun 2022 - Nov 2022 | |
| LILRB4 STAR-T | STAR-T (Specific effector T-cells) | AML | Monotherapy | LILRB4 STAR-T cells | NCT05548088 | Phase I (Completed) | May 2023 - Aug 2024 | |
| LILRB4 STAR-T | STAR-T (Specific effector T-cells) | AML, CMML | Monotherapy | LILRB4 STAR-T cells | NCT05739409 | NA (Unknown status) | Feb 2023 - Aug 2024 | |
| Solid tumors | ||||||||
| LILRB1 | BND-22/SAR444881 | IgG4 mAb | Advanced solid tumors: BC, CC, CRC, EC, GC, HNSCC, HCC, gallbladder cancer, CCA, NSCLC, RCC, CSCC, PC, OC, and urothelial carcinoma | Monotherapy and combination therapy | BND-22/SAR444881 alone; BND-22/SAR444881 + pembrolizumab (anti-PD-1); BND-22/SAR444881 + cetuximab (anti-EGFR) |
NCT04717375 | Phase I/II (Active, not recruiting) | Apr 2021 - Jun 2025 |
| AGEN1571 | IgG4 mAb | Advanced solid tumors | Monotherapy and combination therapy | AGEN1571 alone;AGEN1571 + balstilimab (anti-PD-1);AGEN1571 + botensilimab (anti-CTLA-4);AGEN1571 + balstilimab (anti-PD-1) + botensilimab (anti-CTLA-4) | NCT05377528 | Phase I (Completed) | Jul 2022 - Dec 2024 | |
| ADA-011 | mAb | Advanced solid tumors | Monotherapy and combination therapy | ADA-011 alone; ADA-011 + PD-L1 inhibitor |
NCT05601219 | Phase I (Terminated) | Nov 2022 - Oct 2024 | |
| LILRB2 | JTX-8064 | IgG4 mAb | Advanced solid tumors: ccRCC, TNBC, OC, HNSCC, NSCLC, CSCC, UPS, liposarcoma, BTC | Monotherapy and combination therapy | JTX-8064 alone;JTX-8064 + pembrolizumab (anti-PD-1) | NCT04669899 | Phase I/II (Completed) | Jan 2021 - Nov 2023 |
| IO-108 | IgG4 mAb | Advanced solid tumors | Monotherapy and combination therapy | IO-108 alone; IO-108 + pembrolizumab (anti-PD-1);IO-108 + cemiplimab (anti-PD-1); | NCT05054348 | Phase Ib (Completed) | Sep 2021 - May 2024 | |
| MK-4830 | IgG4 mAb | Advanced solid tumors: PC, glioblastoma, NSCLC, HNSCC, CCRCC, GC, OC, FTC, PPC, BC, mesothelioma | Monotherapy and combination therapy | MK-4830 alone; MK-4830 + pembrolizumab (anti-PD-1); MK-4830 + pembrolizumab (anti-PD-1) + lenvatinib (tyrosine kinase inhibitor), carboplatin, pemetrexed, paclitaxel and cisplatin (chemotherapies) | NCT03564691 | Phase I (Active, not recruiting) | Jul 2018 - Sep 2025 | |
| MK-4830 | IgG4 mAb | High-grade serous OC | Combination therapy | MK-4830 + pembrolizumab (anti-PD-1) + chemotherapy | NCT05446870 | Phase II (Completed) | Jul 2022 - Oct 2024 | |
| ES009 | IgG4 mAb | Advanced solid tumors | Monotherapy | ES009 alone | NCT06007482 | Phase I (Completed) | Sep 2023 - Feb 2025 | |
| LILRB4 | IO-202 | IgG1 mAb | Advanced solid tumors | Monotherapy and combination therapy | IO-202 alone;IO-202 + pembrolizumab (anti-PD-1); RP2D of IO-202 + pembrolizumab (anti-PD-1) | NCT05309187 | Phase I (Completed) | Apr 2022 - May 2024 |
| NGM831 | IgG1 mAb | Advanced solid tumors: PC, BC, GC, NSCLC, CC, endocervical cancer, HNSCC, BUC, CRC, EC, OC, RCC, PCa, Melanoma, Mesothelioma, CCA | Monotherapy and combination therapy | NGM831; NGM831 + pembrolizumab (anti-PD-1); NGM831 + NGM438 (anti-LAIR1) + pembrolizumab (anti-PD-1) |
NCT05215574 | Phase I (Active, not recruiting) | Mar 2022 - Mar 2026 | |
| MK-0482 | IgG4 mAb | Advanced solid tumors | Monotherapy and combination therapy | MK-0482 alone; MK-0482 + pembrolizumab (anti-PD-1); MK-0482 + pembrolizumab (anti-PD-1) + paclitaxel, nab-paclitaxel, gemcitabine, carboplatin and pemetrexed (chemotherapies) |
NCT03918278 | Phase I (Completed) | Jun 2019 - Jun 2025 | |
| MK-0482 | IgG4 mAb | NSCLC | Combination therapy | MK-4830 + pembrolizumab (anti-PD-1) | NCT04165096 | Phase II (Completed) | Jan 2020 - May 2025 | |
| LILRB1 and LILRB2 | NGM707 | BsAb (mAb) | Advanced solid tumors: Mesothelioma, glioblastoma, RCC, NSCLC, Melanoma, PC, GC, HNSCC, CCA, endocervical cancer, BC, OC, CC, CRC, EC | Monotherapy and combination therapy | NGM707 alone; NGM707 + pembrolizumab (anti-PD-1) |
NCT04913337 | Phase I/II (Active, not recruiting) | Jun 2021 - Jul 2025 |
| LILRB2 and PD-1 | CDX-585 | BsAb (IgG-scFv) | Advanced solid tumors: NSCLC, GC, HNSCC, OC, PPC, FTC, BUC, CRC, EC, HCC, RCC, CCA, PC | Monotherapy | CDX-585 alone | NCT05788484 | Phase I (Completed) | May 2023 - May 2025 |
| LILRB1, LILRB2 and KIR3DL1 | IOS-1002 | TsAb (HLA-B57- B2m-IgG4_Fc fusion protein) | Advanced solid tumors | Monotherapy and combination therapy | IOS-1002 alone; IOS-1002 + pembrolizumab (anti-PD-1) |
NCT05763004 | Phase Ia/Ib (Recruiting) | Mar 2023 - May 2025 |
AML, acute myeloid leukemia; BC, breast cancer; BCL-2, B-cell lymphoma 2; BsAb, bispecific antibody; BTC, biliary tract cancer; BUC, bladder urothelial cancer; CAR T, chimeric antigen receptor T-cell; CC, cervical cancer; CCA, cholangiocarcinoma; ccRCC, clear cell renal cell carcinoma; CMML, chronic myelomonocytic leukemia; CRC, colorectal cancer; CSCC, cutaneous squamous cell carcinoma; CTLA-4, cytotoxic T-lymphocyte antigen 4; EC, esophageal carcinoma; EGFR, epidermal growth factor receptor; FTC, fallopian tube cancer; GC, gastric cancer; HCC, hepatocellular carcinoma; HNSCC, head and neck squamous cell carcinoma; IgG-scFv, immunoglobulin G single-chain variable fragment; LAIR1, leukocyte-associated immunoglobulin-like receptor 1; mAb, monoclonal antibody; M-AML, acute myeloid leukemia with monocytic differentiation; NA, not available; NSCLC, non-small cell lung cancer; OC, ovarian cancer; PC, pancreatic cancer; PCa, prostate cancer; PD-1, programmed cell death protein 1; PD-L1, programmed death ligand 1; PPC, primary peritoneal carcinoma; RCC, renal cell carcinoma; STAR‑T, synthetic T-cell receptor and antigen receptor; TNBC, triple-negative breast cancer; TsAb, trispecific antibody; UPS, undifferentiated pleomorphic sarcoma.