Forty patients with pancreatic cancer, sarcoma and carcinoma of breast will receiveDNG64-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 aweek. DNG64-CAR-V may be given alone or with one or more FDA approved cancertherapies/immunotherapies, or with certain FDA authorized investigational agents.Based on previous Phase 1/2 US based clinical studies, DNG64-CAR-V does not suppress thebone marrow or cause organ dysfunction, and enhanced immune cell trafficking in tumorsmay cause the tumors to appear larger or new lesions to appear on CT, PET or MRI(pseudoprogression). Further, tumor stabilization/regression/remission have occurredlater during the treatment period with DNG64-CAR-V monotherapy. Therefore, DNG64 -CAR-Vwill be continued if the patient has clinical benefit and does not have symptomaticdisease progression.
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.
Drug: DNG64-CAR-V
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.
Other Name: DNG64 Chimeric Amphotroopic RNA Vector Encoding a Cyclin G1 Inhibitor
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
Sarcoma Oncology Research Center, LLC
Santa Monica, California, United States
Investigator: ERLINDA M GORDON, MD
Contact: 3105529999
egordon@sarcomaoncology.com
ERLINDA M GORDON, MD
3105529999
egordon@sarcomaoncology.com
Victoria Chua-Alcala, MD
3105529999
vchua@sarcomaoncology.com
ERLINDA M GORDON, MD, Principal Investigator
Sarcoma Oncology Research Center, LLC