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Study of Personalized Tumour Vaccines and a PD-L1 Blocker in Patients With Surgically Resected Pancreatic Adenocarcino

NCT ID: NCT06156267

Last Updated: 2023-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-31

Study Completion Date

2027-03-31

Brief Summary

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This is a phase 1, open-label study to evaluate the safety and tolerability of neoantigen personalized mRNA tumour vaccine combined with Adebrelimab (a PD-L1 humanized monoclonal antibody) in patients with surgically resected pancreatic adenocarcinoma.

Detailed Description

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Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part A: Dose Escalation, Part B: Dose Expansion

Group Type EXPERIMENTAL

Adebrelimab

Intervention Type DRUG

Adebrelimab is a programmed death-ligand 1 antibody.

mRNA tumor vaccines

Intervention Type DRUG

neoantigen personalized mRNA vaccines

Interventions

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Adebrelimab

Adebrelimab is a programmed death-ligand 1 antibody.

Intervention Type DRUG

mRNA tumor vaccines

neoantigen personalized mRNA vaccines

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Voluntarily signed the informed consent form and complied with protocols requirements.
2. Patients with radiographically resectable primary pancreatic tumors with histopathology or cytology confirmed resected ductal pancreatic adenocarcinoma (PDAC) with macroscopic complete resection (R0 and R1).
3. Pancreatic cancer surgical staging per AJCC 8th edition staging: T 1-3, N0-2, M0.
4. Tumour specimen availability.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
6. Life expectancy ≥ 6 months.
7. Surgical complications have recovered, or complications lower than Clavien-Dindo complication grade 3.
8. Adequate marrow and organ function.
9. Patients with fertility are willing to use an adequate method of contraception.

Exclusion Criteria

1. Prior anti-PDAC therapy (e.g., chemotherapy, radiotherapy, targeted therapy, immunotherapy and therapeutic tumor vaccines) prior to initiation of study treatment.
2. Unsuitable for immunotherapy assessed by the investigator.
3. Plan to receive a live-attenuated vaccine within 28 days prior to initiation of study treatment or during the study treatment or within 90 days after the end of study treatment.
4. Have any active autoimmune disease, or have a history of autoimmune disease and have received systemic therapy in the past 2 years.
5. Active tuberculosis or a history of active tuberculosis infection within 28 days prior to initiation of study treatment.
6. Known or highly suspected history of interstitial pneumonia.
7. Allergic to research drug ingredients, or have a history of severe allergic reactions to other vaccines.
8. Prior malignancy within 5 years prior to study entry.
9. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
10. Known splenectomy history.
11. Concurrent severe infection within 28 days prior to initiation of study treatment.
12. Congenital or acquired immune deficiency.
13. Active hepatitis B (HBV-DNA≥1000IU/ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the lower limit of assay).
14. Uncontrolled or severe cardiovascular disease.
15. Other situations that are not suitable for inclusion in this study judged by investigator.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Regenelead Therapies Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Xian-Jun Yu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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PANC-IIT-RGL-mRNA vaccine

Identifier Type: -

Identifier Source: org_study_id