BLESSED: Expanded Access for DNG64-CAR-V for Advanced Pancreatic Cancer, Sarcoma and Carcinoma of Breast

March 2, 2026 updated by: Erlinda M Gordon, Aveni Foundation

Forty patients with pancreatic cancer, sarcoma and carcinoma of breast will receive DNG64-CAR-V intravenously or intratumorally at a dose of 1-4 x 10e11 colony forming units (cfu) or equivalent 1.0-6.0 x 10e10 Vector Copies (VC) per dose one to three times a week. DNG64-CAR-V may be given alone or with one or more FDA approved cancer therapies/immunotherapies, or with certain FDA authorized investigational agents.

Based on previous Phase 1/2 US based clinical studies, DNG64-CAR-V does not suppress the bone marrow or cause organ dysfunction, and enhanced immune cell trafficking in tumors may cause the tumors to appear larger or new lesions to appear on CT, PET or MRI (pseudoprogression). Further, tumor stabilization/regression/remission have occurred later during the treatment period with DNG64-CAR-V monotherapy. Therefore, DNG64 -CAR-V will be continued if the patient has clinical benefit and does not have symptomatic disease progression.

Study Overview

Status

Available

Conditions

Intervention / Treatment

Detailed Description

DNG64-CAR-V is a replication incompetent chimeric tumor targeted amphtropic RNA vector that displays a Sig-binding decapeptide for binding to abnormally exposed Signature (Sig) proteins in the tumor microenvironment (TME) and encoding a CCNG1 inhibitor gene for killing cancer cells, neoangiogenic cells and pro-inflammatory, immune suppressive, stroma producing cancer associated fibroblasts (CAFs), thus reducing inflammation and converting an immune-cold to an immune-hot tumor, and reducing extracellular matrix production in the TME, hence augmenting drug entry and immune cell trafficking into the TME. Enhanced CCNG1 expression has been found in all cancer types tested at the Cancer Center of Southern California as of June 2023. Hence, in July 2023, the USFDA authorized the use of DNG64-CAR-V as platform therapy upon which one or more FDA approved cancer drugs immunotherapies and/or certain FDA authorized investigational agents may be added. This would allow a personalized approach in the treatment of all cancer patients.

Forty patients with pancreatic cancer, sarcoma and carcinoma of breast will receive DNG64-CAR-V intravenously or intratumorally at a dose of 1-4 x 10e11 colony forming units (cfu) or equivalent 1.0-6.0 x 10e10 VC per dose one-three times a week. DNG64-CAR-V may be given alone or with an FDA approved cancer therapy/immunotherapy and/or certain FDA authorized investigational agents on physician discretion.

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Monica, California, United States, 90403
        • Available
        • Sarcoma Oncology Research Center, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 96 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient is ≥12 years of age, either male or female for patients with sarcoma; >18 years of age, either male or female.with pancreatic cancer or carcinoma of breast.
  • Patient has pancreatic cancer or sarcoma or carcinoma of breast confirmed by pathologic examination at diagnosis.
  • Patients with advanced metastatic pancreatic cancer who have received systemic therapies such as FOLFIRINOX and gemcitabine + albumin-bound paclitaxel; patients with metastatic sarcoma who have disease progression after two or more lines of systemic treatments and not amenable to surgical resection or radiotherapy; specifically for osteosarcoma: have disease progression after high dose methotrexate, cisplatinum, doxorubicin and ifosfamide; for soft tissue sarcoma: have disease progression after doxorubicin + ifosfamide/mesna, gemcitabine, docetaxel, dacarbazine, trabectedin, pazopanib, eribulin; patients with metastatic carcinoma of breast who have disease progression with standard therapy (ACT), targeted therapies including aromatase inhibitors, trastuzumab, pertuzumab, enhertu, tyrosine kinase inhibitors, immune checkpoint inhibitors; patient who is intolerant to or declines available therapeutic options after documentation that patient has been informed of the available therapeutic options.
  • Patient is able to understand or is willing to sign a written informed consent.
  • Patient agrees to use barrier contraception during vector infusion period and for 6 weeks after infusion

Exclusion Criteria:

  • Patient is unwilling to provide formal informed consent.
  • Patient is unwilling to use barrier contraception during vector infusion period and for 6 weeks after infusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aveni Foundation

Investigators

  • Principal Investigator: ERLINDA M GORDON, MD, Sarcoma Oncology Research Center, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

August 8, 2019

First Submitted That Met QC Criteria

September 12, 2019

First Posted (Actual)

September 16, 2019

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AF19-200

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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