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

West China Second University Hospital

Status and phase: Unknown; Phase 1

Conditions: Recurrent Ovarian Cancer

Treatments: Biological: dendritic cell

Study type: Interventional

Funder types: Other

Identifiers

NCT05270720

WCSUH2022001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

experimental group

Experimental group

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.

Treatment:

Biological: dendritic cell