P1/2, N=4, Terminated, Istari Oncology, Inc. | N=15 --> 4 | Trial completion date: May 2025 --> Jun 2024 | Recruiting --> Terminated | Trial primary completion date: May 2025 --> Apr 2024; business decision

P1, N=12, Not yet recruiting, University of Florida | Initiation date: Sep 2024 --> Dec 2024

P2, N=56, Active, not recruiting, Istari Oncology, Inc. | Trial primary completion date: Jun 2024 --> Oct 2024

P2, N=25, Completed, Istari Oncology, Inc. | Active, not recruiting --> Completed | Trial completion date: Mar 2024 --> Jun 2024 | Trial primary completion date: Mar 2024 --> Jun 2024

P1, N=12, Terminated, Istari Oncology, Inc. | Completed --> Terminated; Study closed to enrollment due to business decision prior to enrolling Cohort 4

P3, N=195, Active, not recruiting, Canadian Cancer Trials Group | Trial completion date: Apr 2024 --> Dec 2024

P1/2, N=209, Recruiting, NextCure, Inc. | N=131 --> 209

P1, N=12, Not yet recruiting, University of Florida

P2, N=50, Recruiting, Karen Carty

P1; N=45 --> 30

P2, N=33, Active, not recruiting, Albert Einstein College of Medicine | Completed --> Active, not recruiting | Trial completion date: Oct 2022 --> Oct 2024

P2, N=92, Not yet recruiting, Darell Bigner | Initiation date: Apr 2024 --> Jul 2024

P1, N=8, Completed, Istari Oncology, Inc. | Active, not recruiting --> Completed | Phase classification: P1b --> P1 | N=12 --> 8

P2, N=56, Active, not recruiting, Istari Oncology, Inc. | Trial completion date: Oct 2023 --> Oct 2024 | Trial primary completion date: Oct 2023 --> Jun 2024

P1/2, N=75, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Mar 2024 --> Mar 2025

Combining LOAd703 with nab-paclitaxel plus gemcitabine in patients with advanced pancreatic ductal adenocarcinoma was feasible and safe. To build upon this novel chemoimmunotherapeutic approach, arm 2 of LOKON001, which combines LOAd703, nab-paclitaxel plus gemcitabine, and atezolizumab, is ongoing.

P1/2, N=131, Recruiting, NextCure, Inc. | Phase classification: P1b/2 --> P1/2

P2, N=16, Terminated, Washington University School of Medicine | N=24 --> 16 | Trial completion date: Mar 2024 --> Nov 2023 | Recruiting --> Terminated | Trial primary completion date: Mar 2024 --> Nov 2023; Celldex decision

P2, N=92, Not yet recruiting, Darell Bigner | Initiation date: Dec 2023 --> Apr 2024

P2, N=53, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Oct 2025 --> Jan 2025 | Trial primary completion date: Oct 2024 --> Jan 2025

P1/2, N=46, Active, not recruiting, Lokon Pharma AB | Trial completion date: Dec 2024 --> Aug 2024 | Trial primary completion date: Dec 2023 --> Aug 2023

P1, N=15, Recruiting, Chinese PLA General Hospital | N=10 --> 15

P1, N=5, Completed, Istari Oncology, Inc. | Recruiting --> Completed

P1, N=23, Active, not recruiting, Dana-Farber Cancer Institute | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024

However, combined targeting of LAIR-1 and PD-L1 results in increased tumour control. Thus, additional targeting of the LAIR-1:collagen pathway with NC410 is a promising approach to treating tumours where conventional immunotherapy is ineffective.

P1, N=21, Active, not recruiting, University of Florida

P2, N=92, Not yet recruiting, Darell Bigner

Treatment of patients with GC/GEJC with GEN-001 in combination with avelumab in the ≥ 3L setting showed promising antitumor activities with an overall manageable safety profile. The results from this trial will be updated about its effects on clinical outcome, including survival, safety, and biomarker findings. Clinical trial information: NCT05419362.

P1/2, N=90, Completed, University of Chile

P3, N=195, Active, not recruiting, Canadian Cancer Trials Group | Trial primary completion date: Oct 2023 --> Apr 2024

P1, N=21, Active, not recruiting, University of Florida | Recruiting --> Active, not recruiting

This is a single arm phase I pilot study of liposomal doxorubicin, CDX-1140 (CD40 agonist monoclonal antibody), and CDX-301 (recombinant Flt3 ligand) combination therapy in patients with metastatic or unresectable locally advanced metastatic TNBC. Key eligibility criteria are unresectable stage III or stage IV TNBC (ER ≤10%, PR ≤10%, HER2/neu negative), 1st to 3rd line treatment for metastatic disease (1st line patients need to be PD-L1 negative by 22C3 assay), measurable disease by RECIST 1.1 criteria, consent for pre-treatment and on-treatment biopsies of amenable soft tissue tumor lesions, no prior treatment with an anti-CD40 antibody or a Flt3 ligand, no anthracycline treatment in the metastatic setting, no prior progression while on anthracycline-based therapy or within 6 months of completing neoadjuvant chemotherapy, and no history of non-infectious pneumonitis or current pneumonitis. This trial will enroll up to 45 patients across multiple sites (NCT05029999) and is currently open at University of Texas Southwestern Medical Center, Texas Oncology, University of Chicago, University of Texas San Antonio, Sarah Cannon Research Institute, and Johns Hopkins.

Background: Patients with intermediate and higher-risk MDS are generally treated with the DNA hypomethylating agents (HMAs) azacytidine and decitabine...This open-label, non-randomized single center Phase 1 study used an HLA unrestricted NY-ESO-1 vaccine (CDX-1401 (1 mg) + poly-ICLC (1.8 mg)) in combination with standard dose decitabine (20mg/m2/d x 5 days) and nivolumab (3 mg/kg every 2 weeks), 4 cycles of combination therapy were planned on study; patients deriving clinical benefit could continue treatment at the discretion of the treating physician... These results suggest that the use of immunotherapy to induce effective, cytotoxic anti-tumor T cell responses depends upon the myeloid immunologic milieu in MDS patients. The critical importance of cDC1 function has recently been described and appreciated in the context of solid tumor immunotherapy. The observation of both numerical and functional defects of this cell population in patients with myeloid neoplasia provides a possible explanation for the disappointing efficacy of immunotherapies in this disease state.

P2, N=42, Active, not recruiting, Genome & Company | Recruiting --> Active, not recruiting

P2, N=148, Recruiting, Genome & Company | Not yet recruiting --> Recruiting

In this study, we investigated whether monocyte vaccination in combination with CDX-301, a DC-expanding cytokine Fms-like tyrosine kinase 3 ligand (Flt3L), could improve the antitumor efficacy of anti-programmed cell death (anti-PD-1) immune checkpoint blockade...To our knowledge, this is the first demonstration that a cancer vaccine strategy and Flt3L can improve the antitumor efficacy of anti-PD-1. The findings presented here warrant further study of how monocyte vaccines can improve Flt3L and immune checkpoint blockade as they enter clinical trials.

Additionally, the combined treatment resulted in a less immunosuppressive TME, indicated by decreased infiltration of myeloid-derived suppressor cells and Tregs. These findings suggest that the combination of intratumoral AlloDCs administration with systemic agonistic α4-1BB treatment can generate a synergistic anti-tumor response, thereby warranting further investigation through clinical studies.

P1, N=15, Completed, M.D. Anderson Cancer Center | Active, not recruiting --> Completed

P1, N=10, Recruiting, Chinese PLA General Hospital | Initiation date: Feb 2023 --> Jul 2023

P2, N=42, Recruiting, Genome & Company | Trial completion date: Sep 2024 --> Dec 2024 | Trial primary completion date: Sep 2024 --> Dec 2024

P1/2, N=5, Terminated, Albert Einstein College of Medicine | N=46 --> 5 | Trial completion date: Aug 2024 --> Aug 2022 | Recruiting --> Terminated | Trial primary completion date: Dec 2023 --> Aug 2022; Low accrual

P3, N=195, Active, not recruiting, Canadian Cancer Trials Group | Trial completion date: Jun 2023 --> Apr 2024 | Trial primary completion date: Jun 2023 --> Oct 2023