Table 5.
Current ongoing clinical trials for the new B7 family checkpoint molecule-specific antagonist agents.
| Name of the compound | Mechanism of action | Study phase | Trial ID | Targeted population | Status |
|---|---|---|---|---|---|
| SCRI-CARB7H3(s); B7H3-specific chimeric antigen receptor T (CAR-T) cell | Autologous CD4+ and CD8+ T cells lentivirally transduced to express a B7H3-specific CAR and EGFRt | Phase I | ClinicalTrials.gov NCT04185038 |
Patients with diffuse intrinsic pontine glioma/diffuse midline glioma and recurrent or refractory pediatric central nervous system tumors | Recruiting |
| Temozolomide | Interact with DNA and repair processes | Phases I and II | ClinicalTrials.gov NCT04077866 |
Patients with recurrent glioblastoma Patients with refractory glioblastoma |
Recruiting |
| Temozolomide + B7-H3 CAR-T cells | Interact with DNA and repair processes + a retroviral vector encoding a CAR targeting B7-H3 | ||||
| Second-generation 4-1BBζ B7H3-EGFRt-DHFR | Autologous CD4+ and CD8+ T-cells lentivirally transduced to express a second-generation 4-1BBζ B7H3-EGFRt-DHFR | Phase I | ClinicalTrials.gov NCT04483778 |
Patients with recurrent/refractory solid tumors in children and young adults | Recruiting |
| Second-generation 4-1BBζ B7H3-EGFRt-DHFR (selected) and a second-generation 4-1BBζ CD19-Her2tG | Autologous CD4+ and CD8+ T cells lentivirally transduced to express a second-generation 4-1BBζ B7H3-EGFRt-DHFR (selected) and a second-generation 4-1BBζ CD19-Her2tG | ||||
| CAR-T cell therapy | CAR-T cells targeting HER2, mesothelin, PSCA, MUC1, Lewis-Y, GPC3, AXL, EGFR, Claudin18.2, or B7-H3 | Phase I | ClinicalTrials.gov NCT03198052 |
Immunotherapy of patients with lung cancer | Recruiting |
| 4SCAR-276 | Targeting CD276 (B7-H3)-positive solid tumors | Phase I/II | ClinicalTrials.gov NCT04432649 |
Patients with refractory and/or recurrent solid tumor | Recruiting |
| B7-H3 CAR-T + temozolomide | Targeting B7-H3 antigen + interact with DNA and repair processes | Phase I | ClinicalTrials.gov NCT04385173 |
Patients with recurrent and refractory glioblastoma | Recruiting |
| CAR.B7-H3 + fludarabine + cyclophosphamide | Targeting the B7-H3 antigen + DNA synthesis inhibitor + cell apoptosis (DNA crosslinks both between and within DNA strands at guanine N-7 positions) | Phase I | ClinicalTrials.gov NCT04670068 |
Patients with recurrent epithelial ovarian cancer | Recruiting |
| MGC018 | Anti-B7-H3 antibody drug conjugate | Phase I/II | ClinicalTrials.gov NCT03729596 |
Patients with advanced solid tumors | Active, not recruiting |
| MGC018 + MGA012 | Anti-B7-H3 antibody–drug conjugate + anti-PD-1 antibody | ||||
| Enoblituzumab + retifanlimab | Anti-B7-H3 antibody + anti-PD-1 antibody | Phase II | ClinicalTrials.gov NCT04634825 |
Patients with recurrent or metastatic squamous cell carcinoma of the head and neck | Terminated |
| Enoblituzumab + tebotelimab | Anti-B7-H3 antibody + PD-1 and LAG-3 bispecific DART molecule | ||||
| 4SCAR-T | Targeting GD2, PSMA, and CD276 | Phase I/II | ClinicalTrials.gov NCT04637503 |
Patients with relapsed and refractory neuroblastoma | Recruiting |
| Engineered TILs/CAR-TILs | Targeting HER2, mesothelin, PSCA, MUC1, Lewis-Y, GPC3, AXL, EGFR, Claudin18.2/6, ROR1, GD1, or B7-H3 | Phase 1 | ClinicalTrials.gov NCT04842812 |
Patients with advanced solid tumors | Recruiting |
| BI 765049 | Limited information is currently available | Phase I | ClinicalTrials.gov NCT04752215 |
Adults with advanced solid tumors whose previous cancer treatment was not successful | Recruiting |
| BI 765049 + BI 754091 | Limited information is currently available + anti-PD-1 |
EGFR, epidermal growth factor receptor; LAG-3, lymphocyte activation gene-3; PD-1, programmed cell death-1; SCCHN, squamous cell carcinoma of the head and neck; TIL, tumor-infiltrating lymphocyte.