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Solid TumorNCT03842865

Expanded Access of Vigil in Solid Tumors

A study testing Vigil in people with Solid Tumor and Ewing Sarcoma, run by Gradalis, Inc. at 1 site in United States.

Temporarily Not Available

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is an expanded access study involving an investigational product named Vigil. Vigil is considered immunotherapy. Patients who participated in another clinical trial sponsored by Gradalis, and had Vigil made from their tumor tissue removed from a standard operation, however failed the criteria to enroll in the… Read more about this study

Who is it for?
Ages 2 years and older
What is being tested?
Vigil
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 2 years and older
  • All sexes
  • Child, Adult, Older adult

Study Enrollment Inclusion Criteria:

  1. Histologically confirmed advanced or metastatic non-curable solid tumor.
  2. Completed manufacture of at least 1 vial of Vigil, but failure of one or more manufacturing release criteria.
  3. ECOG performance status (PS) 0-1 or Karnofsky performance status (KPS) / Lansky performance status (LS)≥ 70%.
  4. Normal organ and marrow function as defined below: Absolute granulocyte count ≥1,000/mm3, Absolute lymphocyte count ≥400/mm3, Platelets ≥75,000/mm3, Hemoglobin ≥ 8.0 mg/dL, Total bilirubin ≤ institutional upper limit of normal*, AST(SGOT)/ALT(SGPT) ≤2x institutional upper limit of normal, Creatinine <1.5 mg/dL *documented Gilbert's syndrome may be considered after medical monitor review
  5. No systemic therapy, immunologic therapy or investigational therapy within 2 weeks and no radiation therapy within 1 week prior to enrollment.
  6. Subject has recovered to CTCAE Grade 1 (except for parameters noted in Item 4, above) or better from all adverse events associated with prior therapy or surgery. Pre-existing motor, sensory neurologic pathology or symptoms, or dermatologic toxicities must be recovered to CTCAE Grade 2 or better.
  7. If female of childbearing potential, has a negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a negative serum test will be required for study entry.
  8. Ability to understand and the willingness to sign a written informed protocol specific consent or a parental/guardian informed consent and pediatric assent when appropriate.

Study Enrollment Exclusion Criteria:

  1. Medical condition requiring any form of chronic systemic immunosuppressive therapy (steroid or other) except physiologic replacement doses of hydrocortisone or equivalent (no more than 30 mg hydrocortisone or 10 mg prednisone equivalent daily) for < 30 days duration.
  2. Known history of other malignancy unless having undergone curative intent therapy without evidence of that disease for ≥ 3 years except cutaneous squamous cell and basal cell skin cancer, superficial bladder cancer, in situ cervical cancer or other in situ cancers are allowed if definitively resected.
  3. Receipt of greater than 2 lines of systemic treatment between Vigil manufacture and screening for this protocol.
  4. Live vaccine used for the prevention of infectious disease administered < 30 days prior to the start of study therapy.
  5. Post-surgery complication that in the opinion of the treating investigator would interfere with the subject's study participation or make it not in the best interest of the patient to participate.
  6. Brain metastases unless treated with curative intent (gamma knife or surgical resection) and without evidence of progression for ≥ 2 months.
  7. Any documented history of autoimmune disease with exception of Type 1 diabetes on stable insulin regimen, hypothyroidism on stable dose of replacement thyroid medication, vitiligo, or asthma not requiring systemic steroids.
  8. Known HIV or chronic Hepatitis B or C infection.
  9. Known history of allergies or sensitivities to gentamicin.
  10. History of or current evidence of any condition (including medical, psychiatric or substance abuse disorder), therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Texas Oncology - Pediatrics

    Dallas, Texas, 75230

Other trials in United States

About this study

Official title: An Expanded Access Trial of Vigil (Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Advanced Solid Tumors

This is an expanded access study involving an investigational product named Vigil. Vigil is considered immunotherapy. Patients who participated in another clinical trial sponsored by Gradalis, and had Vigil made from their tumor tissue removed from a standard operation, however failed the criteria to enroll in the other clinical trial to receive Vigil are eligible to screen for this expanded access trial to receive the Vigil made from their cancer cells.

In this study, eligible participants will receive intradermal (under the skin) injections of Vigil, once every 4 weeks (28 days) for 1-12 doses, depending on the number of doses that was made from the cancer cells and if the participant is clinically stable. During the treatment portion of the study, in addition to receiving Vigil injections, participants will also have a physical exam, blood collection for routine and research tests, and assessment of medications, adverse events, and performance status information will be collected. Radiological tumor assessments will be performed every 3 months from Cycle 1. Once treatment ends, participants will continue to be seen in the clinic every 3 months for similar assessments until disease progression occurs. After disease progression, participants will be contacted by phone 4 times a year to determine post study treatment and survival status information.

Read the detailed description

This is an Expanded Access trial of Vigil (bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Advanced Solid Tumors. Approximately 40 subjects who had tissue procured and Vigil manufactured but fail manufacturing release criteria under a previous Gradalis protocol are considered for this study.

Eligible participants will receive a minimum of 1 and a maximum of 12 doses of Vigil intradermal injections every 4 weeks as monotherapy. Participants will be managed in an outpatient setting. Hematologic function, liver enzymes, renal function and electrolytes will be monitored. Blood for immune function analyses in response to autologous tumor antigens will be collected at screening, Day 1 (prior to Vigil administration) at Cycles 2, 4, and 6, end of treatment (EOT); 3 months after EOT, and every 6 months thereafter for those in response follow up. For subjects with Ewing's sarcoma, blood for ctDNA analysis will be collected at screening, on Day 1 prior to Vigil administration at Cycles 2, 3, 4, and 6, and EOT.

Being tested
Vigil
Keywords
Immunotherapy
Medical subject headings
Sarcoma, Ewing, Ovarian Neoplasms, Uterine Cervical Neoplasms, Uterine Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VigilBiological

    Also called Engineered Autologous Tumor Cell Immunotherapy, FANG, IND 14205

    Vigil is composed of autologous tumor cells harvested from the patient at the time of initial de-bulking surgery which are then transfected extracorporeally, with a plasmid encoding for the gene for GM-CSF, an immune-stimulatory cytokine, and a bifunctional, short hairpin RNA which specifically knocks down the expression of furin, the critical convertase responsible for production of the two TGβ isoforms (TGFβ-1 and TGFβ-2).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Expanded access
IDs, dates and publications
ClinicalTrials.gov ID
NCT03842865
Sponsor's protocol ID
CL-PTL-132
Status last verified
Jun 2025
First submitted
13 Feb 2019
Last updated
5 Jun 2025
Results posted
No

Publications

  • Senzer N, Barve M, Kuhn J, Melnyk A, Beitsch P, Lazar M, Lifshitz S, Magee M, Oh J, Mill SW, Bedell C, Higgs C, Kumar P, Yu Y, Norvell F, Phalon C, Taquet N, Rao DD, Wang Z, Jay CM, Pappen BO, Wallraven G, Brunicardi FC, Shanahan DM, Maples PB, Nemunaitis J. Phase I trial of "bi-shRNAi(furin)/GMCSF DNA/autologous tumor cell" vaccine (FANG) in advanced cancer. Mol Ther. 2012 Mar;20(3):679-86. doi: 10.1038/mt.2011.269. Epub 2011 Dec 20.

    PubMed 22186789

  • Ghisoli M, Barve M, Mennel R, Lenarsky C, Horvath S, Wallraven G, Pappen BO, Whiting S, Rao D, Senzer N, Nemunaitis J. Three-year Follow up of GMCSF/bi-shRNA(furin) DNA-transfected Autologous Tumor Immunotherapy (Vigil) in Metastatic Advanced Ewing's Sarcoma. Mol Ther. 2016 Aug;24(8):1478-83. doi: 10.1038/mt.2016.86. Epub 2016 Apr 25.

    PubMed 27109631

  • Ghisoli M, Barve M, Schneider R, Mennel R, Lenarsky C, Wallraven G, Pappen BO, LaNoue J, Kumar P, Nemunaitis D, Roth A, Nemunaitis J, Whiting S, Senzer N, Fletcher FA, Nemunaitis J. Pilot Trial of FANG Immunotherapy in Ewing's Sarcoma. Mol Ther. 2015 Jun;23(6):1103-1109. doi: 10.1038/mt.2015.43. Epub 2015 Mar 19.

    PubMed 25917459

  • Ghisoli M, Rutledge M, Stephens PJ, Mennel R, Barve M, Manley M, Oliai BR, Murphy KM, Manning L, Gutierrez B, Rangadass P, Walker A, Wang Z, Rao D, Adams N, Wallraven G, Senzer N, Nemunaitis J. Case Report: Immune-mediated Complete Response in a Patient With Recurrent Advanced Ewing Sarcoma (EWS) After Vigil Immunotherapy. J Pediatr Hematol Oncol. 2017 May;39(4):e183-e186. doi: 10.1097/MPH.0000000000000822.

    PubMed 28338569

  • Oh J, Barve M, Matthews CM, Koon EC, Heffernan TP, Fine B, Grosen E, Bergman MK, Fleming EL, DeMars LR, West L, Spitz DL, Goodman H, Hancock KC, Wallraven G, Kumar P, Bognar E, Manning L, Pappen BO, Adams N, Senzer N, Nemunaitis J. Phase II study of Vigil(R) DNA engineered immunotherapy as maintenance in advanced stage ovarian cancer. Gynecol Oncol. 2016 Dec;143(3):504-510. doi: 10.1016/j.ygyno.2016.09.018. Epub 2016 Sep 24.

    PubMed 27678295

  • Rocconi RP, Grosen EA, Ghamande SA, Chan JK, Barve MA, Oh J, Tewari D, Morris PC, Stevens EE, Bottsford-Miller JN, Tang M, Aaron P, Stanbery L, Horvath S, Wallraven G, Bognar E, Manning L, Nemunaitis J, Shanahan D, Slomovitz BM, Herzog TJ, Monk BJ, Coleman RL. Gemogenovatucel-T (Vigil) immunotherapy as maintenance in frontline stage III/IV ovarian cancer (VITAL): a randomised, double-blind, placebo-controlled, phase 2b trial. Lancet Oncol. 2020 Dec;21(12):1661-1672. doi: 10.1016/S1470-2045(20)30533-7.

    PubMed 33271095

  • Oh J, Barve M, Senzer N, Aaron P, Manning L, Wallraven G, Bognar E, Stanbery L, Horvath S, Manley M, Nemunaitis J, Walter A, Rocconi RP. Long-term follow-up of Phase 2A trial results involving advanced ovarian cancer patients treated with Vigil(R) in frontline maintenance. Gynecol Oncol Rep. 2020 Sep 17;34:100648. doi: 10.1016/j.gore.2020.100648. eCollection 2020 Nov. No abstract available.

    PubMed 33364285

Questions about this trial

What is this clinical trial studying?

A study testing Vigil in people with Solid Tumor and Ewing Sarcoma, run by Gradalis, Inc. 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?

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 5 Jun 2025. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03842865, which also lists 7 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 5 Jun 2025.

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Expanded Access of Vigil in Solid Tumors (NCT03842865) | AzTrials