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CDX-301

DRUG8 trials

Sponsors

Celldex Therapeutics, Weill Medical College of Cornell University, Washington University School of Medicine, Dana-Farber Cancer Institute, Ashutosh Kumar Tewari

Conditions

Acute Lymphoblastic Leukemia (ALL)Acute Myelogenous Leukemia (AML)Bladder Urothelial CarcinomaBreast CancerCancer of the PancreasCholangiocarcinomaChronic Lymphocytic Leukemia (CLL)Chronic Myelogenous Leukemia (CML)

Phase 1

A Study to Evaluate CDX-301 (rhuFlt3L) in Healthy Volunteers
CompletedNCT01465139
Celldex TherapeuticsHealthy
Start: 2011-10-31End: 2013-01-31Updated: 2017-06-27
A Study of CDX-1140 (CD40) as Monotherapy or in Combination in Patients With Advanced Malignancies
CompletedNCT03329950
Celldex TherapeuticsBladder Urothelial Carcinoma, Breast Cancer, Cholangiocarcinoma +23
Start: 2017-12-01End: 2022-09-13Updated: 2024-03-28
NeoVax + CDX-301 and Nivolumab or Pembrolizumab in Melanoma
Active, not recruitingNCT04930783
Dana-Farber Cancer InstituteMelanoma, Metastatic Melanoma
Start: 2022-01-03End: 2030-09-30Updated: 2026-03-25
The Safety and Tolerability of PGV001-based Personalized Multi-peptide Vaccines in the Adjuvant Setting.
Active, not recruitingNCT05010200
Ashutosh Kumar TewariProstate Cancer
Start: 2022-01-05End: 2028-01-31Updated: 2026-01-07
CD40 Agonist, Flt3 Ligand, and Chemotherapy in HER2 Negative Breast Cancer
RecruitingNCT05029999
University of Texas Southwestern Medical CenterHER2-negative Breast Cancer, Metastatic Breast Cancer
Start: 2022-04-20End: 2026-04-20Target: 30Updated: 2025-08-13

Phase 2

A Safety and Tolerability Study of CDX-301 With or Without Plerixafor for Stem Cell Mobilization in Matched Related Allogeneic Donor/Recipient Sibling Transplant Pairs
TerminatedNCT02200380
Celldex TherapeuticsAcute Lymphoblastic Leukemia (ALL), Acute Myelogenous Leukemia (AML), Chronic Lymphocytic Leukemia (CLL) +7
Start: 2014-07-31End: 2016-04-13Updated: 2017-04-07
Converting HR+ Breast Cancer Into an Individualized Vaccine
RecruitingNCT03804944
Weill Medical College of Cornell UniversityBreast Cancer
Start: 2020-03-17End: 2027-12-31Target: 100Updated: 2026-01-28
Immunologic Effects of CDX-301 and CDX-1140 in Resectable Pancreatic Cancer Patients
TerminatedNCT04536077
Washington University School of MedicineCancer of the Pancreas, Pancreas Cancer, Pancreatic Cancer
Start: 2021-08-13End: 2023-11-21Updated: 2024-10-08

Related Papers

Abstract LB-B008: cDC expansion and CD40 activation after immunogenic chemotherapy shift the breast tumor microenvironment toward functional T cell immunity and IL-12-dependent tumor control
Cancer Immunology Research2026-03-05
Abstract PS5-08-28: Phase I pilot of pegylated liposomal doxorubicin, CD40 agonist antibody CDX-1140, and Flt3 ligand CDX-301 in advanced HER2-negative breast cancer
Clinical Cancer Research2026-02-17
Abstract P3-12-30: Phase I trial of pegylated liposomal doxorubicin chemotherapy in combination with CD40 agonist and Flt3 ligand in metastatic HER2 negative breast cancer
Clinical Cancer Research2025-06-13
Abstract 6171: Flt3 ligand and CD40 agonist-based therapy in breast cancer promotes myeloid cell CXCL9 secretion and CD8 T cell recruitment but is not dependent on CXCL9 for efficacy
Cancer Research2025-04-21
Abstract PO1-19-08: Phase I trial of pegylated liposomal doxorubicin chemotherapy in combination with CD40 agonist and Flt3 ligand in metastatic triple-negative breast cancer
Cancer Research2024-05-02
Abstract 5314: Improved breast cancer tumor control with addition of CD40 agonist and Flt3 ligand to pegylated liposomal doxorubicin is only partially mediated by CD8 T cells
Cancer Research2024-03-221 citations
First-in-human study of SBRT and adenosine pathway blockade to potentiate the benefit of immunochemotherapy in early-stage luminal B breast cancer: results of the safety run-in phase of the Neo-CheckRay trial
Journal for ImmunoTherapy of Cancer2023-12-0118 citations
Abstract OT2-17-01: Phase 1 trial of anthracycline chemotherapy in combination with CD40 agonist and Flt3 ligand in metastatic triple-negative breast cancer
Cancer Research2023-03-01
596 Results from a phase 1 study of CDX-1140, a fully human anti-CD40 agonist monoclonal antibody (mAb), in combination with pembrolizumab
Regular and Young Investigator Award Abstracts2022-11-014 citations
Abstract 4197: Treatment with chemotherapy, CD40 agonist, and Flt3 ligand triplet combination enhances antigen presentation and leads to cures in triple negative breast cancer
Cancer Research2022-06-15
Phase 1 pilot study with dose expansion of chemotherapy in combination with CD40 agonist and Flt3 ligand in metastatic triple-negative breast cancer.
Journal of Clinical Oncology2022-06-013 citations
Neo-CheckRay: radiation therapy and adenosine pathway blockade to increase benefit of immuno-chemotherapy in early stage luminal B breast cancer, a randomized phase II trial.
2021-08-0627 citations
405 CDX1140–01, a phase 1 dose-escalation/expansion study of CDX-1140 alone (Part 1) and in combination with CDX-301 (Part 2) or pembrolizumab (Part 3)
Regular and Young Investigator Award Abstracts2020-11-018 citations
Baseline T cell dysfunction by single cell network profiling in metastatic breast cancer patients
Journal for ImmunoTherapy of Cancer2019-07-1153 citations
Abstract LB-194: First-in-human Phase I study of the CD40 agonist mAb CDX-1140 and in combination with CDX-301 (rhFLT3L) in patients with advanced cancers: Interim results
Cancer Research2019-07-019 citations
Abstract LB-194: First-in-human Phase I study of the CD40 agonist mAb CDX-1140 and in combination with CDX-301 (rhFLT3L) in patients with advanced cancers: Interim results
Immunology2019-07-01