New gene therapy offers hope for advanced cancers
NCT ID NCT04091295
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This expanded access program provides DNG64-CAR-V, a gene therapy, to patients with advanced pancreatic cancer, sarcoma, or breast cancer who have exhausted standard treatments. The therapy is given intravenously or directly into tumors, alone or with other cancer drugs. Early studies suggest it may stabilize or shrink tumors without severe side effects like bone marrow suppression.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- DNG64-CAR-V (a gene therapy vector that targets cancer cells)
- What this could lead to
- If it works, this could provide a new treatment option for people with advanced cancers that have not responded to standard therapies.
- What could go wrong
- This is an expanded access program, not a controlled trial, so results are uncertain. Tumors may appear to grow before shrinking (pseudoprogression), and not all patients will benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sarcoma Oncology Research Center, LLC
AVAILABLESanta Monica, California, 90403, United States
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