Trial Summary
What is the purpose of this trial?
This is a phase 1, first in human, dose escalation study for safety and feasibility of multi-dose dendritic cell (DC) therapy for pancreatic ductal adenocarcinoma (PDAC) including adenosquamous carcinoma administered after surgical resection of PDAC.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot be on systemic steroids or immunosuppressive agents within 7 days before starting Step 2 of the trial.
What data supports the effectiveness of the treatment Autologous DC vaccine for pancreatic cancer?
Is dendritic cell immunotherapy safe for humans?
How is the dendritic cell immunotherapy treatment for pancreatic cancer different from other treatments?
This treatment uses a vaccine made from the patient's own dendritic cells (a type of immune cell) that are loaded with tumor antigens to specifically target and attack pancreatic cancer cells, which is different from traditional treatments like chemotherapy that do not target specific cancer cells.13789
Research Team
Benjamin Musher
Principal Investigator
Baylor College of Medicine
Eligibility Criteria
Adults over 18 with pancreatic adenocarcinoma that's potentially removable and who've finished standard chemo and surgery. They must have good organ function, no HIV, Hepatitis B or C (with exceptions), no autoimmune diseases, not be on steroids/immunosuppressants recently, and agree to contraception if of childbearing potential.Inclusion Criteria
I am a man who can father children and will use contraception during and for 12 weeks after the study.
I have a type of pancreatic cancer that doctors think can be surgically removed and I'm considered a good candidate for additional chemotherapy.
I have finished all my initial cancer treatments and surgery as recommended.
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Exclusion Criteria
I am on a unique chemotherapy plan not typically used.
I am not pregnant, breastfeeding, and if of childbearing age, I have a recent negative pregnancy test.
Any severe or uncontrolled medical condition or other condition that could affect participation in this study (in the opinion of the investigator), including but not limited to: hyper/hypothyroidism, active systemic autoimmune disorders, untreated viral hepatitis or autoimmune hepatitis.
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Standard Chemotherapy
Participants complete standard chemotherapy for pancreatic adenocarcinoma
Varies
Dendritic Cell Vaccine Treatment
Participants receive 3 doses of dendritic cell vaccine, one every 14 days, with weekly peg-interferon a-2a
6 weeks
3 visits (in-person) for vaccination, weekly visits for peg-interferon
Follow-up
Participants are monitored for safety and effectiveness after treatment
6 weeks
Long-term Follow-up
Participants are monitored for recurrence and overall survival
Up to 3 years
Treatment Details
Interventions
- Autologous DC vaccine
Trial Overview This phase 1 trial tests the safety of a dendritic cell vaccine for pancreatic cancer patients. It involves escalating doses given three times post-standard treatments to see how well patients tolerate it.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Autologous DC Therapy Group B Cohort 2Experimental Treatment1 Intervention
The DC therapy is manufactured from autologous dendritic cells loaded with tumor cell lysate and RNA. Patients will receive 2 doses of DC therapy (separated by 14 days) and be monitored (vital signs every 30 minutes) for 2 hours after each dose. During intervention, patients receive weekly peg-IFN at 180 mcg/week on the first day of administration up through 14 days after last dose.
DC Therapy dose evaluated in Group B Cohort 2:
First Cycle 1st dose - 12 million cells First Cycle 2nd dose - 12 million cells Second Cycle 1st dose - 12 million cells (optional) Second Cycle 2nd dose - 12 million cells (optional)
Patients in Group B cohort 2 will receive the DC therapy after neoadjuvant chemotherapy and surgery (1st cycle), with an option for additional DC therapy (2nd cycle) after adjuvant chemotherapy.
Group II: Autologous DC Therapy Group B Cohort 1Experimental Treatment1 Intervention
The DC therapy is manufactured from autologous dendritic cells loaded with tumor cell lysate and RNA. Patients will receive 2 doses of DC therapy (separated by 14 days) and be monitored (vital signs every 30 minutes) for 2 hours after each dose. During intervention, patients receive weekly peg-IFN at 180 mcg/week on the first day of administration up through 14 days after last dose.
DC Therapy dose evaluated in Group B Cohort 1:
First Cycle 1st dose - 8 million cells First Cycle 2nd dose - 8 million cells Second Cycle 1st dose - 8 million cells (optional) Second Cycle 2nd dose - 8 million cells (optional)
Patients in Group B cohort 1 will receive the DC therapy after neoadjuvant chemotherapy and surgery (1st cycle), with an option for additional DC therapy (2nd cycle) after adjuvant chemotherapy.
Group III: Autologous DC Therapy Group AExperimental Treatment1 Intervention
ENROLLMENT IN THIS ARM HAS BEEN COMPLETED
The DC therapy is manufactured from autologous dendritic cells loaded with autologous tumor cell lysate and mRNA. Patients will receive 3 doses of DC therapy (one every 14 days) and be monitored (vital signs every 30 minutes) for 2 hours after each dose. During intervention, patients receive weekly peg-IFN at 180 mcg/week on the first day of administration up through 14 days after last dose.
DC Therapy dose evaluated in Group A:
1. st dose - 0.5 million cells
2. nd dose - 1 million cells
3. rd dose - 2 million cells
Patients in Group A will receive the DC therapy after neoadjuvant chemotherapy, surgery and adjuvant chemotherapy.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Diakonos Oncology Corporation
Lead Sponsor
Trials
1
Recruited
140+
Baylor College of Medicine
Collaborator
Trials
1,044
Recruited
6,031,000+
Cancer Cures for Kids
Collaborator
Trials
1
Recruited
40+
Findings from Research
The dendritic cell (DC) vaccine modified with tumor lysate and Interleukin-18 (IL-18) significantly enhanced immune responses in a mouse model of pancreatic carcinoma, leading to higher levels of IL-18 and IFN-gamma compared to other treatment groups.
Mice treated with the DC-IL18-Lysate vaccine remained tumor-free for at least 50 days and had a median survival of over 62 days, which was significantly longer than other groups, indicating its potential efficacy as a therapeutic vaccine against pancreatic cancer.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
The immunotherapeutic effect of dendritic cells vaccine modified with interleukin-18 gene and tumor cell lysate on mice with pancreatic carcinoma.Tang, ZH., Qiu, WH., Wu, GS., et al.[2019]
In a study of 7 patients with advanced pancreatic ductal adenocarcinoma (PDA) receiving a WT1-targeting dendritic cell vaccine combined with chemotherapy, those who responded well (super-responders) had significantly lower levels of plasma matrix metalloproteinase-9 and systemic inflammatory markers compared to non-responders.
Lower cytoplasmic expression of WT1 in PDA cells was also associated with better overall survival, suggesting that both low inflammatory responses and low WT1 expression may serve as predictive markers for patient outcomes in this treatment approach.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Predicted Markers of Overall Survival in Pancreatic Cancer Patients Receiving Dendritic Cell Vaccinations Targeting WT1.Ito, Z., Kan, S., Bito, T., et al.[2019]
References
Dendritic cell-based vaccination of patients with advanced pancreatic carcinoma: results of a pilot study. [2020]
Prognostic factors related to add-on dendritic cell vaccines on patients with inoperable pancreatic cancer receiving chemotherapy: a multicenter analysis. [2023]
The immunotherapeutic effect of dendritic cells vaccine modified with interleukin-18 gene and tumor cell lysate on mice with pancreatic carcinoma. [2019]
Dendritic cell immunotherapy induces anti-tumor effect in a transgenic mouse model of pancreatic ductal adenocarcinoma. [2021]
Predicted Markers of Overall Survival in Pancreatic Cancer Patients Receiving Dendritic Cell Vaccinations Targeting WT1. [2019]
A practical approach to pancreatic cancer immunotherapy using resected tumor lysate vaccines processed to express α-gal epitopes. [2018]
The feasibility and safety of immunotherapy with dendritic cells loaded with CEA mRNA following neoadjuvant chemoradiotherapy and resection of pancreatic cancer. [2020]
Generation and functional characterisation of dendritic cells from patients with pancreatic carcinoma with special regard to clinical applicability. [2019]
[Immunotherapeutic effects of beta-elemene combined with interleukin-23 gene-modified dendritic cells on murine pancreatic carcinoma]. [2018]
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