Table 3. Representative ongoing clinical... | Rockefeller University Press

Table 3.

Representative ongoing clinical trials investigating strategies for (1) cDC1 mobilization and activation and (2) cDC1-based vaccination

Trial phase and number	Tumor type	Approach	Rationale—preclinical/clinical	Refs
1. cDC1 mobilization and activation strategies
Phase I/II—Recruiting (NCT03789097)	HNSCC, MBC, indolent NHL	In situ delivery of CDX-301 (FLT3L), poly-ICLC, localized low-dose radiotherapy, and systemic delivery of pembrolizumab	Therapeutic strategy was well tolerated and showed early signs of efficacy in NHL and MBC patients, including instance of regression of large metastatic tumor in patient (Marron et al., 2022)	Hammerich et al. (2019) and Marron et al. (2022)
Phase I—recruiting (NCT05029999)	Metastatic or unresectable stage III/IV HER2 negative breast cancer (TNBC or HR(+))	Intravenous PEGylated liposomal doxorubicin (PLD) and CDX-1140 (agonistic anti-CD40 mAb), subcutaneous CDX-301	Combination of PLD, CD40 agonist mAb, and FLT3L promoted tumor control in the TNBC 4T1 mouse model (Ramani et al., 2022)	Ramani et al. (2022) and Reddy et al. (2023)
Phase I—active (NCT04616248)	Range of solid tumors—unresectable melanoma, squamous cell carcinoma, basal cell carcinoma, Merkel cell carcinoma, bone or soft tissue sarcoma, HER(−) breast cancer	(A) In situ delivery of CDX-1140, CDX-301, poly-ICLC, and localized radiotherapy (B) In situ delivery of CDX-1140, CDX-301, poly-ICLC, and localized radiotherapy. IV delivery of pembrolizumab and SC tocilizumab (anti-IL-6)	Combinations of intratumoral FLT3L, peritumoral poly-ICLC, and agonistic CD40 mAb, and localized radiotherapy led to clearance of non–T cell–inflamed murine tumor models (AT-3, B16, and 4T1)	Ito et al. (2024)
2. cDC1-based cellular vaccine approaches
Phase I/II—recruiting (NCT05773859)	Epithelial ovarian cancer	Autologous tumor lysate–loaded cDC1s. cDC1s isolated from peripheral circulation of patients. cDC1 vaccination will be given in combination with standard-of-care carboplatin/paclitaxel and cytoreductive therapy	Advances in cell sorting technologies allowing purification of cDC1s in sufficient quantity from peripheral blood. Enhanced cDC1 functionality compared with alternative DC vaccination platforms (see Table 2)	Koeneman et al. (2025)

Trial phase and number	Tumor type	Approach	Rationale—preclinical/clinical	Refs
1. cDC1 mobilization and activation strategies
Phase I/II—Recruiting (NCT03789097)	HNSCC, MBC, indolent NHL	In situ delivery of CDX-301 (FLT3L), poly-ICLC, localized low-dose radiotherapy, and systemic delivery of pembrolizumab	Therapeutic strategy was well tolerated and showed early signs of efficacy in NHL and MBC patients, including instance of regression of large metastatic tumor in patient (Marron et al., 2022)	Hammerich et al. (2019) and Marron et al. (2022)
Phase I—recruiting (NCT05029999)	Metastatic or unresectable stage III/IV HER2 negative breast cancer (TNBC or HR(+))	Intravenous PEGylated liposomal doxorubicin (PLD) and CDX-1140 (agonistic anti-CD40 mAb), subcutaneous CDX-301	Combination of PLD, CD40 agonist mAb, and FLT3L promoted tumor control in the TNBC 4T1 mouse model (Ramani et al., 2022)	Ramani et al. (2022) and Reddy et al. (2023)
Phase I—active (NCT04616248)	Range of solid tumors—unresectable melanoma, squamous cell carcinoma, basal cell carcinoma, Merkel cell carcinoma, bone or soft tissue sarcoma, HER(−) breast cancer	(A) In situ delivery of CDX-1140, CDX-301, poly-ICLC, and localized radiotherapy(B) In situ delivery of CDX-1140, CDX-301, poly-ICLC, and localized radiotherapy. IV delivery of pembrolizumab and SC tocilizumab (anti-IL-6)	Combinations of intratumoral FLT3L, peritumoral poly-ICLC, and agonistic CD40 mAb, and localized radiotherapy led to clearance of non–T cell–inflamed murine tumor models (AT-3, B16, and 4T1)	Ito et al. (2024)
2. cDC1-based cellular vaccine approaches
Phase I/II—recruiting (NCT05773859)	Epithelial ovarian cancer	Autologous tumor lysate–loaded cDC1s. cDC1s isolated from peripheral circulation of patients. cDC1 vaccination will be given in combination with standard-of-care carboplatin/paclitaxel and cytoreductive therapy	Advances in cell sorting technologies allowing purification of cDC1s in sufficient quantity from peripheral blood. Enhanced cDC1 functionality compared with alternative DC vaccination platforms (see Table 2)	Koeneman et al. (2025)

HNSCC, head and neck squamous cell carcinoma; MBC, metastatic breast cancer; NHL, non-Hodgkin’s lymphoma.