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Expanded Access of Vigil in Solid Tumors

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ClinicalTrials.gov Identifier: NCT03842865
Expanded Access Status : Available
First Posted : February 15, 2019
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Gradalis, Inc.

Brief Summary:
This is a multicenter, expanded access protocol of intradermal autologous Vigil immunotherapy. Subjects meeting expanded access eligibility criteria will receive a minimum of 1 immunotherapy dose of Vigil (1 x 10e4, 1 x 10e5, or 1 x 10e6 cells/injection), intradermally every 4 weeks as monotherapy.

Condition or disease Intervention/treatment
Solid Tumor Ewing Sarcoma Ewing's Tumor Metastatic Ewing's Sarcoma Metastatic Advanced Gynecological Cancers Ovarian Cancer Cervical Cancer Uterine Cancer Biological: Vigil

Detailed Description:

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.

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.


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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population
Official Title: An Expanded Access Trial of Vigil (Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Advanced Solid Tumors



Intervention Details:
  • Biological: Vigil
    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).
    Other Names:
    • Engineered Autologous Tumor Cell Immunotherapy
    • FANG
    • IND 14205

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03842865


Contacts
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Contact: Gladice Wallraven 214-442-8124 info@gradalisinc.com

Locations
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United States, Texas
Texas Oncology - Pediatrics
Dallas, Texas, United States, 75230
Contact: Maurizio Ghisoli, MD    972-566-6647    Maurizio.Ghisoli@usoncology.com   
Sponsors and Collaborators
Gradalis, Inc.
Investigators
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Study Director: Luisa Manning, MD Gradalis, Inc.

Publications of Results:
Other Publications:
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Responsible Party: Gradalis, Inc.
ClinicalTrials.gov Identifier: NCT03842865     History of Changes
Other Study ID Numbers: CL-PTL-132
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Keywords provided by Gradalis, Inc.:
Immunotherapy
Additional relevant MeSH terms:
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Sarcoma
Sarcoma, Ewing
Uterine Neoplasms
Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms by Site
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Diseases
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Modafinil
Physiological Effects of Drugs
Central Nervous System Stimulants
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action