Table 2.
Ongoing clinical trials in melanoma for modified cell therapies.
| Study Name (NCT Number) | Trial Stage | Therapeutic Approach | Enrollment | Disease/Stage |
|---|---|---|---|---|
| (NCT02870244) | Phase I (Recruiting) | TIL 1383I TCR transduced T-cells | 18 | Advanced melanoma |
| (NCT01586403) | Phase I (Active, not recruiting) | Two doses of autologous T-cell receptor transduced T-cells, administered along with IL-2 | 14 | Stage IV melanoma patients |
| (NCT02650986) | Phase I/II (Active, not recruiting) | Genetically modified T-cells, with or without concurrent decitabine | 15 | Advanced melanoma, ovarian, fallopian, peritoneal, and synovial cancers |
| (NCT02869217) | Phase I (Active, not recruiting) | TBI-1301 (TCR gene transduced autologous T lymphocyte) after cyclophosphamide and fludarabine pre-treatment | 22 | Solid tumors, including melanoma |
| (NCT05296564) | Phase I/II (Recruiting) | HBI-0201 (TCR gene-engineered lymphocytes) | 3 | NY-ESO-1 expressing metastatic cancers, including stage IV melanoma |
| (NCT03132922) | Phase I (Active, not recruiting) | MAGE-A4c1032 modified T-cell therapy | 71 | HLA-A2 positive participants with MAGE-A4 positive tumors, including melanoma |
| (NCT04897321) | Phase I (Recruiting) | B7-H3-specific CAR T-cells, administered after lymphodepleting chemotherapy | 32 | B7-H3-positive tumors, including melanoma |
| (NCT04483778) | Phase I (Active, not recruiting) | B7H3-specific CAR T-cells vs. B7H3-CD19-specific CAR T-cells vs. B7H3-CD19-specific CAR T-cells and pembrolizumab | 68 | Recurrent/refractory solid tumors, including melanoma in children and young adults |
| (NCT04119024) | Phase I (Recruiting) | IL13Ralpha2 CAR T-cells | 18 | Stage IIIc or IV melanoma and other metastatic solid tumors |
| (NCT04729543) | Phase I/II (Recruiting) | MAGE-C2/HLA-A2 TCR T-cells | 20 | Melanoma and head and neck cancer |
| (NCT05415072) | Phase I/II (Recruiting) | Single-agent DYP688 | 124 | Metastatic uveal melanoma (MUM) and other melanomas with GNAQ/11 mutations |
| (NCT05588453) | Phase I/II (Recruiting) | Natural killer cell therapy (UD TGFbetai NK cells) and temozolomide | 30 | Stage IV melanoma metastatic to the brain |
| (NCT05629546) | Phase I (Not Yet Recruiting) | Autologous: Memory-like natural killer cells + nivolumab + relatilimab and Allogeneic: Memory-like natural killer cells + nivolumab + relatilimab | 33 | Advanced or metastatic melanoma that has progressed after at least 12 weeks or a minimum of 2 doses of treatment with a standard of care |
| (NCT03420963) | Phase I (Recruiting) | Cyclophosphamide + etoposide + NK cells | 38 | Patients with relapsed or refractory solid tumors |