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Recurrent Ovarian CancerPhase 1NCT05270720

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

A Phase 1 study testing dendritic cell in people with Recurrent Ovarian Cancer, run by West China Second University Hospital at 1 site in China.

Unknown status

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 The sponsor has not verified this record for over two years, so it may be out of date.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

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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Recurrent Ovarian Cancer
What is being tested?
dendritic cell
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteChina
Study dates
1 Sep 2022to 1 Mar 2024
Phase
Phase 1
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 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • west china second University， SICHUAN University, China

    Chengdu, Sichuan, 610016

    rutie YIN, M.D., yinrutie@motherchildren.com

    Qintong LI, M.D.

Other trials in China

About this study

Official title: Dendritic Cell Vaccination for the Adult Ovarian Cancer

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.

Read the 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.

Being tested
dendritic cell
Keywords
neoantigen, dendritic cell vaccine
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • dendritic cellBiological

    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.

Study groups in NCT05270720
Study groupRoleWhat they receive
experimental groupExperimentalThis 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.
Receives: Biological: dendritic cell

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. adverse events

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

    Measured: up to 18 months

Secondary outcomes (3)

  1. Pharmacodynamics

    percentage of antigen-specific T cells in peripheral blood.

    Measured: up to 1 week

  2. PFS

    Progression-free survival

    Measured: up to 18 months

  3. OS

    Overall survival

    Measured: up to 18 months

Timeline

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

  1. First posted8 Mar 2022
  2. Study start1 Sep 2022 (estimated)
  3. Primary completion1 Sep 2023 (estimated)
  4. Study completion1 Mar 2024 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05270720
Sponsor's protocol ID
WCSUH2022001
Status last verified
Feb 2022
First submitted
12 Feb 2022
Last updated
8 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28830889

  • 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.

    PubMed 25837513

  • 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.

    PubMed 29843811

  • 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.

    PubMed 33064988

  • 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.

    PubMed 32764681

  • 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.

    PubMed 30306202

  • 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.

    PubMed 29643231

  • Wang W, Jiang J, Yang C, Meng X, Gao L, Yuan Y, Lei T, Ding P, Yin R, Li Q. A critical time window for leukapheresis product transportation to manufacture clinical-grade dendritic cells with optimal anti-tumor activities. Cytotherapy. 2024 Feb;26(2):210-220. doi: 10.1016/j.jcyt.2023.12.003. Epub 2023 Dec 19.

    PubMed 38127032

  • Li Q, Yang C, Tian H, Jiang J, Li P, Zhu X, Lei T, Yin R, Ding P, Bai P, Li Q. Development of a personalized dendritic cell vaccine and single-cell RNA sequencing-guided assessment of its cell type composition. Cytotherapy. 2023 Feb;25(2):210-219. doi: 10.1016/j.jcyt.2022.10.013. Epub 2022 Nov 25.

    PubMed 36443171

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing dendritic cell in people with Recurrent Ovarian Cancer, run by West China Second University Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. 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 8 Mar 2022. 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 China. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

adverse events (time frame: up to 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05270720, which also lists 9 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 8 Mar 2022.

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