Pancreatic CancerNCT04091295
BLESSED: Expanded Access for DNG64-CAR-V for Advanced Pancreatic Cancer, Sarcoma and Carcinoma of Breast
A study testing DNG64-CAR-V in people with Pancreatic Cancer and Osteosarcoma, run by Aveni Foundation at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 100 years
- Conditions the study is for
- Pancreatic Cancer, Osteosarcoma, MPNST (Malignant Peripheral Nerve Sheath Tumor)
- What is being tested?
- DNG64-CAR-V
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
- Available
Sarcoma Oncology Research Center, LLC
Santa Monica, California, 90403
ERLINDA M GORDON, MD, 3105529999, egordon@sarcomaoncology.com
Victoria Chua-Alcala, MD, 3105529999 ext. Chawla, santchawla@sarcomaoncology.com
About this study
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.
Read the 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.
- Conditions
- Pancreatic Cancer, Osteosarcoma, MPNST (Malignant Peripheral Nerve Sheath Tumor), Chondrosarcoma, Soft Tissue Sarcoma, Chordoma
- Being tested
- DNG64-CAR-V
- Keywords
- tumor targeted gene therapy, human cyclin G1 inhibitor, cell cycle control, CCNG1 inhibitor
- Medical subject headings
- Pancreatic Neoplasms, Osteosarcoma, Neurofibrosarcoma, Chondrosarcoma, Sarcoma, Chordoma, Breast Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNG64-CAR-VDrug
Also called DNG64 Chimeric Amphotroopic RNA Vector Encoding a Cyclin G1 Inhibitor
Intravenous or intratumoral infusions of DNG64-CAR-V for treatment of advanced pancreatic cancer, sarcoma and carcinoma of breast and other FDA authorized cancer types.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Aveni Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erlinda M Gordon, Aveni Foundation
- Investigators
- ERLINDA M GORDON, MD, Principal investigator, Sarcoma Oncology Research Center, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091295
- Sponsor's protocol ID
- AF19-200
- Status last verified
- Mar 2026
- First submitted
- 8 Aug 2019
- Last updated
- 4 Mar 2026
- Results posted
- No
Publications
Kim S, Federman N, Gordon EM, Hall FL, Chawla SP. Rexin-G(R), a tumor-targeted retrovector for malignant peripheral nerve sheath tumor: A case report. Mol Clin Oncol. 2017 Jun;6(6):861-865. doi: 10.3892/mco.2017.1231. Epub 2017 Apr 28.
PubMed 28588778Chawla SP, Chawla NS, Quon D, Chua-Alcala V, Blackwelder WC, Hall FL and Gordon EM: An advanced phase 1/2 study using an XC-targeted gene therapy vector for chemotherapy resistant sarcoma. Sarcoma Res Int 3: 1024, 2016
Gordon EM, Hall FL. Rexin-G, a targeted genetic medicine for cancer. Expert Opin Biol Ther. 2010 May;10(5):819-32. doi: 10.1517/14712598.2010.481666.
PubMed 20384524Chawla SP, Chua VS, Fernandez L, Quon D, Saralou A, Blackwelder WC, Hall FL, Gordon EM. Phase I/II and phase II studies of targeted gene delivery in vivo: intravenous Rexin-G for chemotherapy-resistant sarcoma and osteosarcoma. Mol Ther. 2009 Sep;17(9):1651-7. doi: 10.1038/mt.2009.126. Epub 2009 Jun 16.
PubMed 19532136Chawla SP, Bruckner H, Morse MA, Assudani N, Hall FL, Gordon EM. A Phase I-II Study Using Rexin-G Tumor-Targeted Retrovector Encoding a Dominant-Negative Cyclin G1 Inhibitor for Advanced Pancreatic Cancer. Mol Ther Oncolytics. 2018 Dec 14;12:56-67. doi: 10.1016/j.omto.2018.12.005. eCollection 2019 Mar 29.
PubMed 30705966Al-Shihabi A, Chawla SP, Hall FL, Gordon EM. Exploiting Oncogenic Drivers along the CCNG1 Pathway for Cancer Therapy and Gene Therapy. Mol Ther Oncolytics. 2018 Dec 12;11:122-126. doi: 10.1016/j.omto.2018.11.002. eCollection 2018 Dec 21. No abstract available.
PubMed 30581985Bruckner HW, Chawla SP, Omelchenko N, Brigham DA, Gordon EM. Phase I-II study using DeltaRex-G, a tumor-targeted retrovector encoding a cyclin G1 inhibitor for metastatic carcinoma of breast. Front Mol Med. 2023 May 18;3:1105680. doi: 10.3389/fmmed.2023.1105680. eCollection 2023.
PubMed 39086675Chawla SP, Olevsky O, Iyengar G, Brigham DA, Omelchenko N, Thomas S, Suryamohan K, Foshag L, Hall FL, Gordon EM. Early-stage CCNG1+ HR+ HER2+ Invasive Breast Carcinoma in Older Women: Current Treatment and Future Perspectives for DeltaRex-G, a CCNG1 Inhibitor. Anticancer Res. 2023 Jun;43(6):2383-2391. doi: 10.21873/anticanres.16406.
PubMed 37247916
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BLESSED: Expanded Access for DNG64-CAR-V for Advanced Pancreatic Cancer, Sarcoma and Carcinoma of Breast
- ClinicalTrials.gov ID
- NCT04091295
- Acronym / sponsor ID
- AF19-200
- Conditions
- Pancreatic Cancer, Osteosarcoma, MPNST (Malignant Peripheral Nerve Sheath Tumor), Chondrosarcoma, Soft Tissue Sarcoma, Chordoma
- Keywords
- tumor targeted gene therapy, human cyclin G1 inhibitor, cell cycle control, CCNG1 inhibitor
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Aveni FoundationUniversity, hospital or other
- First posted
- 16 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
Who may qualify
- Ages
- 12 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNG64-CAR-VAlso: DNG64 Chimeric Amphotroopic RNA Vector Encoding a Cyclin G1 InhibitorIntravenous or intratumoral infusions of DNG64-CAR-V for treatment of advanced pancreatic cancer, sarcoma and carcinoma of breast and other FDA authorized cancer types. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Background: PubMed 28588778Kim S, Federman N, Gordon EM, Hall FL, Chawla SP. Rexin-G(R), a tumor-targeted retrovector for malignant peripheral nerve sheath tumor: A case report. Mol Clin Oncol. 2017 Jun;6(6):861-865. doi: 10.3892/mco.2017.1231. Epub 2017 Apr 28.
- BackgroundChawla SP, Chawla NS, Quon D, Chua-Alcala V, Blackwelder WC, Hall FL and Gordon EM: An advanced phase 1/2 study using an XC-targeted gene therapy vector for chemotherapy resistant sarcoma. Sarcoma Res Int 3: 1024, 2016
- Background: PubMed 20384524Gordon EM, Hall FL. Rexin-G, a targeted genetic medicine for cancer. Expert Opin Biol Ther. 2010 May;10(5):819-32. doi: 10.1517/14712598.2010.481666.
- Background: PubMed 19532136Chawla SP, Chua VS, Fernandez L, Quon D, Saralou A, Blackwelder WC, Hall FL, Gordon EM. Phase I/II and phase II studies of targeted gene delivery in vivo: intravenous Rexin-G for chemotherapy-resistant sarcoma and osteosarcoma. Mol Ther. 2009 Sep;17(9):1651-7. doi: 10.1038/mt.2009.126. Epub 2009 Jun 16.
- Background: PubMed 30705966Chawla SP, Bruckner H, Morse MA, Assudani N, Hall FL, Gordon EM. A Phase I-II Study Using Rexin-G Tumor-Targeted Retrovector Encoding a Dominant-Negative Cyclin G1 Inhibitor for Advanced Pancreatic Cancer. Mol Ther Oncolytics. 2018 Dec 14;12:56-67. doi: 10.1016/j.omto.2018.12.005. eCollection 2019 Mar 29.
- Background: PubMed 30581985Al-Shihabi A, Chawla SP, Hall FL, Gordon EM. Exploiting Oncogenic Drivers along the CCNG1 Pathway for Cancer Therapy and Gene Therapy. Mol Ther Oncolytics. 2018 Dec 12;11:122-126. doi: 10.1016/j.omto.2018.11.002. eCollection 2018 Dec 21. No abstract available.
- Background: PubMed 39086675Bruckner HW, Chawla SP, Omelchenko N, Brigham DA, Gordon EM. Phase I-II study using DeltaRex-G, a tumor-targeted retrovector encoding a cyclin G1 inhibitor for metastatic carcinoma of breast. Front Mol Med. 2023 May 18;3:1105680. doi: 10.3389/fmmed.2023.1105680. eCollection 2023.
- Background: PubMed 37247916Chawla SP, Olevsky O, Iyengar G, Brigham DA, Omelchenko N, Thomas S, Suryamohan K, Foshag L, Hall FL, Gordon EM. Early-stage CCNG1+ HR+ HER2+ Invasive Breast Carcinoma in Older Women: Current Treatment and Future Perspectives for DeltaRex-G, a CCNG1 Inhibitor. Anticancer Res. 2023 Jun;43(6):2383-2391. doi: 10.21873/anticanres.16406.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ERLINDA M GORDON, MD principal investigator
Sarcoma Oncology Research Center, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DNG64-CAR-V in people with Pancreatic Cancer and Osteosarcoma, run by Aveni Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ERLINDA M GORDON, MD (3105529999, egordon@sarcomaoncology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04091295, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.