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Dendritic Cell Vaccination With Standard Postoperative Chemotherapy for the Treatment of Adult Ovarian Cancer

Primary Purpose

Recurrent Ovarian Cancer

Status
Not yet recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
dendritic cell
Sponsored by
West China Second University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Ovarian Cancer focused on measuring neoantigen, dendritic cell vaccine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18-75 years old female patients；
  2. Histopathologically diagnosed recurrent stage III/IV epithelial ovarian cancer;
  3. Normal liver, heart as well as kidney functions and blood chemistry;
  4. Predicted survival for more than 6 months；
  5. Provision of signed and dated informed consent form.

Exclusion Criteria:

  1. Allergic to human albumin, an excipient of the manufactured dendric cell vaccine；
  2. Predicted survival for less than 6 months；
  3. Diagnosed with brain metastasis and other diseases unsuitable for cell therapy including but not limited to Myelodysplastic Syndromes、Acute Myeloid Leukemia and Systemic Lupus Erythematosus;
  4. Diagnosed with viral diseases including but not limited to HIV, TP, HCV and HBV ；
  5. Female patients who are pregnant, breast feeding, or of childbearing potential without a negative pregnancy test prior to baseline;
  6. Other conditions deemed unsuitable for this study by the leading investigators.

Sites / Locations

  • west china second University， SICHUAN University, China

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

experimental group

Arm Description

This arm will evaluate the safety of administering a total dendritic cell dose of 5x106. A total of 3 to 6 patients will be enrolled. If this dose is associated with unacceptable side effects, as detailed in the study protocol, no further patients will be enrolled at this dose.

Outcomes

Primary Outcome Measures

adverse events
Patients will be monitored for adverse events as dictated by CTCAE version 5.

Secondary Outcome Measures

Pharmacodynamics
percentage of antigen-specific T cells in peripheral blood.
PFS
Progression-free survival
OS
Overall survival

Full Information

First Posted
February 12, 2022
Last Updated
February 25, 2022
Sponsor
West China Second University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05270720
Brief Title
Dendritic Cell Vaccination With Standard Postoperative Chemotherapy for the Treatment of Adult Ovarian Cancer
Official Title
Dendritic Cell Vaccination for the Adult Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Second University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Effective treatments are desperately needed for ovarian cancer patients. This phase I clinical trial assesses the safety of a novel personalized dendritic-cell vaccine administered to ovarian cancer patients. Secondary outcomes will be evaluated such as patient pharmacodynamics， progression-free survival and overall survival.
Detailed Description
This is a single arm, non-randomized phase I study to evaluate the safety and feasibility of delivering a novel dendritic cell vaccine in 6 to 12 (n=6-12) adult patients diagnosed with ovarian cancer after undergoing surgical resection. The vaccine contains both tumor-associated antigen and patient specific neoantigens. Standard-of-care chemotherapy therapy will be followed as per routine,during which patients enrolled into this study will receive a personalized vaccine in addition to standard of care. Effective adjuvant therapies are urgently needed for these patients given that high rate of recurrence still occurs after standard of care with poor prognosis among ovarian cancer patients. The study is constructed in a 3+3 algorithm for two steps of dose escalation with rigorous and mandatory safety monitoring.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Ovarian Cancer
Keywords
neoantigen, dendritic cell vaccine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
This arm will evaluate the safety of administering a total dendritic cell dose of 5x106. A total of 3 to 6 patients will be enrolled. If this dose is associated with unacceptable side effects, as detailed in the study protocol, no further patients will be enrolled at this dose.
Intervention Type
Biological
Intervention Name(s)
dendritic cell
Intervention Description
Biological: Dendritic Cell Immunotherapy Adult patients with histopathologically diagnosed Ovarian Cancer will be eligible for this novel, personalized dendritic cell vaccine during course of standard of care chemotherapy. If unacceptable side effects are observed at a total dose of 5x106, as detailed in the study protocol, then a cohort of 3-6 enrolled patients will receive a de-escalated total dendritic cell dose of 2.5x106. If no unacceptable side effects are identified at a total dose of 5x106, as detailed in the study protocol, then a cohort of 3-6 enrolled patients will receive an escalated total dendritic cell dose of 1X107.
Primary Outcome Measure Information:
Title
adverse events
Description
Patients will be monitored for adverse events as dictated by CTCAE version 5.
Time Frame
up to 18 months
Secondary Outcome Measure Information:
Title
Pharmacodynamics
Description
percentage of antigen-specific T cells in peripheral blood.
Time Frame
up to 1 week
Title
PFS
Description
Progression-free survival
Time Frame
up to 18 months
Title
OS
Description
Overall survival
Time Frame
up to 18 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-75 years old female patients； Histopathologically diagnosed recurrent stage III/IV epithelial ovarian cancer; Normal liver, heart as well as kidney functions and blood chemistry; Predicted survival for more than 6 months； Provision of signed and dated informed consent form. Exclusion Criteria: Allergic to human albumin, an excipient of the manufactured dendric cell vaccine； Predicted survival for less than 6 months； Diagnosed with brain metastasis and other diseases unsuitable for cell therapy including but not limited to Myelodysplastic Syndromes、Acute Myeloid Leukemia and Systemic Lupus Erythematosus; Diagnosed with viral diseases including but not limited to HIV, TP, HCV and HBV ； Female patients who are pregnant, breast feeding, or of childbearing potential without a negative pregnancy test prior to baseline; Other conditions deemed unsuitable for this study by the leading investigators.
Facility Information:
Facility Name
west china second University， SICHUAN University, China
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610016
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
rutie YIN, M.D.
Email
yinrutie@motherchildren.com
First Name & Middle Initial & Last Name & Degree
Qintong LI, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28830889
Citation
Anguille S, Van de Velde AL, Smits EL, Van Tendeloo VF, Juliusson G, Cools N, Nijs G, Stein B, Lion E, Van Driessche A, Vandenbosch I, Verlinden A, Gadisseur AP, Schroyens WA, Muylle L, Vermeulen K, Maes MB, Deiteren K, Malfait R, Gostick E, Lammens M, Couttenye MM, Jorens P, Goossens H, Price DA, Ladell K, Oka Y, Fujiki F, Oji Y, Sugiyama H, Berneman ZN. Dendritic cell vaccination as postremission treatment to prevent or delay relapse in acute myeloid leukemia. Blood. 2017 Oct 12;130(15):1713-1721. doi: 10.1182/blood-2017-04-780155. Epub 2017 Aug 22.
Results Reference
background
PubMed Identifier
25837513
Citation
Carreno BM, Magrini V, Becker-Hapak M, Kaabinejadian S, Hundal J, Petti AA, Ly A, Lie WR, Hildebrand WH, Mardis ER, Linette GP. Cancer immunotherapy. A dendritic cell vaccine increases the breadth and diversity of melanoma neoantigen-specific T cells. Science. 2015 May 15;348(6236):803-8. doi: 10.1126/science.aaa3828. Epub 2015 Apr 2.
Results Reference
background
PubMed Identifier
29843811
Citation
Liau LM, Ashkan K, Tran DD, Campian JL, Trusheim JE, Cobbs CS, Heth JA, Salacz M, Taylor S, D'Andre SD, Iwamoto FM, Dropcho EJ, Moshel YA, Walter KA, Pillainayagam CP, Aiken R, Chaudhary R, Goldlust SA, Bota DA, Duic P, Grewal J, Elinzano H, Toms SA, Lillehei KO, Mikkelsen T, Walbert T, Abram SR, Brenner AJ, Brem S, Ewend MG, Khagi S, Portnow J, Kim LJ, Loudon WG, Thompson RC, Avigan DE, Fink KL, Geoffroy FJ, Lindhorst S, Lutzky J, Sloan AE, Schackert G, Krex D, Meisel HJ, Wu J, Davis RP, Duma C, Etame AB, Mathieu D, Kesari S, Piccioni D, Westphal M, Baskin DS, New PZ, Lacroix M, May SA, Pluard TJ, Tse V, Green RM, Villano JL, Pearlman M, Petrecca K, Schulder M, Taylor LP, Maida AE, Prins RM, Cloughesy TF, Mulholland P, Bosch ML. First results on survival from a large Phase 3 clinical trial of an autologous dendritic cell vaccine in newly diagnosed glioblastoma. J Transl Med. 2018 May 29;16(1):142. doi: 10.1186/s12967-018-1507-6. Erratum In: J Transl Med. 2018 Jun 29;16(1):179.
Results Reference
background
PubMed Identifier
33064988
Citation
Ott PA, Hu-Lieskovan S, Chmielowski B, Govindan R, Naing A, Bhardwaj N, Margolin K, Awad MM, Hellmann MD, Lin JJ, Friedlander T, Bushway ME, Balogh KN, Sciuto TE, Kohler V, Turnbull SJ, Besada R, Curran RR, Trapp B, Scherer J, Poran A, Harjanto D, Barthelme D, Ting YS, Dong JZ, Ware Y, Huang Y, Huang Z, Wanamaker A, Cleary LD, Moles MA, Manson K, Greshock J, Khondker ZS, Fritsch E, Rooney MS, DeMario M, Gaynor RB, Srinivasan L. A Phase Ib Trial of Personalized Neoantigen Therapy Plus Anti-PD-1 in Patients with Advanced Melanoma, Non-small Cell Lung Cancer, or Bladder Cancer. Cell. 2020 Oct 15;183(2):347-362.e24. doi: 10.1016/j.cell.2020.08.053.
Results Reference
background
PubMed Identifier
32764681
Citation
Harari A, Graciotti M, Bassani-Sternberg M, Kandalaft LE. Antitumour dendritic cell vaccination in a priming and boosting approach. Nat Rev Drug Discov. 2020 Sep;19(9):635-652. doi: 10.1038/s41573-020-0074-8. Epub 2020 Aug 6.
Results Reference
result
PubMed Identifier
30306202
Citation
Zhang W, Lu X, Cui P, Piao C, Xiao M, Liu X, Wang Y, Wu X, Liu J, Yang L. Phase I/II clinical trial of a Wilms' tumor 1-targeted dendritic cell vaccination-based immunotherapy in patients with advanced cancer. Cancer Immunol Immunother. 2019 Jan;68(1):121-130. doi: 10.1007/s00262-018-2257-2. Epub 2018 Oct 10.
Results Reference
result
PubMed Identifier
29643231
Citation
Tanyi JL, Bobisse S, Ophir E, Tuyaerts S, Roberti A, Genolet R, Baumgartner P, Stevenson BJ, Iseli C, Dangaj D, Czerniecki B, Semilietof A, Racle J, Michel A, Xenarios I, Chiang C, Monos DS, Torigian DA, Nisenbaum HL, Michielin O, June CH, Levine BL, Powell DJ Jr, Gfeller D, Mick R, Dafni U, Zoete V, Harari A, Coukos G, Kandalaft LE. Personalized cancer vaccine effectively mobilizes antitumor T cell immunity in ovarian cancer. Sci Transl Med. 2018 Apr 11;10(436):eaao5931. doi: 10.1126/scitranslmed.aao5931.
Results Reference
result

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Dendritic Cell Vaccination With Standard Postoperative Chemotherapy for the Treatment of Adult Ovarian Cancer

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