Th-1 Dendritic Cell Immunotherapy Plus Standard Chemotherapy for Pancreatic Adenocarcinoma

Part of paid clinical trials in Houston, Texas.

Sponsor
Diakonos Oncology Corporation
Study ID
NCT04157127
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Autologous DC Therapy — BIOLOGICAL
    Autologous DC Therapy

Study Details

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.

Key Dates

Start date
Aug 3, 2020
Status verified
May 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Autologous DC Therapy Group B Cohort 1
    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.
  • Experimental: Autologous DC Therapy Group B Cohort 2
    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.
  • Experimental: Autologous DC Therapy Group A
    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.

Primary Outcome Measure

Safety of DC Therapy [ Time Frame: From treatment start until 6 weeks after. ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Baylor College of Medicine Medical Center - McNair CampusHoustonTexas77030
Benjamin Musher, MD
[email protected]
713-798-4292
Baylor St. Lukes Medical CenterHoustonTexas77030
Benjamin Musher
[email protected]
713-798-4292
Dan L. Duncan Cancer Center at Baylor College of MedicineHoustonTexas77030
Clinical Trials Office - Dan L. Duncan Cancer Center at Baylor
713-798-1297

Find similar trials in Houston, TX

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Baylor College of Medicine Medical Center - McNair Campus· Houston, TXBaylor St. Lukes Medical Center· Houston, TXDan L. Duncan Cancer Center at Baylor College of Medicine· Houston, TX

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