DC Vaccine in Colorectal Cancer

NCT03730948 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: UPCC 16218, 831453R01CA204261
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study to assess the safety and tolerability, as well as the immune response rate, of mDC3 vaccine in patients with colorectal cancer.

Conditions

Colorectal Cancer

Keywords

colorectal cancer; cancer vaccine; dendritic cell vaccine

Outcome Measures

Primary Outcomes (2)

• Changes in Numbers of Peptide-specific CD8+ T Cells (Post-vaccine Immune Response)

  Assessment of cellular immune activity may occur via the application of flow cytometry. Numbers of peptide-specific CD8+ T cells will be measured by flow cytometric-based intracellular cytokine or tetramer staining. Flow cytometric assays will include an examination of the influence of immunotherapy on the ability of subject T cells to exhibit phenotypic markers associated with cytolytic potential (e.g. IFN-y, IL-2, TNF-alpha, Granzyme B) after short-term stimulation by mutated peptide and p-HLA multimer staining. PBMC responses against a pool of known antigenic Cytomegalovirus, Epstein Barr Virus and Influenza epitopes will be evaluated in order to track general cellular immune competence during the study.

  Screening, Day 1, Day 43, Day 85. Also at following timepoints, which will vary by subject: 7-14 days after last vaccine; 30 days after last vaccine; every 3 months beginning 6 months since first vaccine until month 12.

• Adverse Events Experienced by Subjects (i.e. Safety of DC Vaccine in Subjects With Surgically Resected Hypermutated CRC)

  Number of subjects who experienced adverse events. Detailed adverse event data is presented in the AE section.

  Through study completion (at 12 months)

Secondary Outcomes (1)

• Percentage of CD8+ Cells in Primary Tumor Tissue

  Screening, Day 1, Day 43, Day 85. Also at following timepoints, which will vary by subject: 7-14 days after last vaccine; 30 days after last vaccine; every 3 months beginning 6 months since first vaccine until month 12.

Study Arms (1)

All subjects

EXPERIMENTAL

All subjects will receive the vaccine and be followed per the schedule of procedures.

Biological: DC vaccine

Interventions

DC vaccine BIOLOGICAL

DC vaccine for colorectal cancer

All subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically-confirmed stage I and II hypermutated colorectal cancer (CRC)
• Surgically resected disease
• Male or female patients 18+ years of age
• ECOG performance status 0-1
• Certain laboratory values, performed within 14 days prior to consent
• Subjects of reproductive potential must agree to use a medically accepted birth control method during the trial and for at least two months following the trial.
• Provide written informed consent

You may not qualify if:

• Prior malignancy within 3 years that may put subject at risk
• Pregnant or nursing women
• Concurrent treatment with systemic immunosuppressants including corticosteroids, calcineurin inhibitors, antiproliferative agents within 2 weeks of consent. Local (inhaled or topical) steroids or replacement dose prednisone are permitted.
• Known allergy to eggs
• Any uncontrolled intercurrent illness or active ongoing infection thta may put subject at additional risk

Sponsors & Collaborators

• University of Pennsylvania: lead
• Parker Institute for Cancer Immunotherapy: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

lentiviral minigene vaccine of COVID-19 coronavirus

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Regulatory Lead
• Organization: University of Pennsylvania

psom-ind-ide@pobox.upenn.edu

215-662-4484

Study Officials

• Kim Reiss-Binder, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: November 5, 2018
• Study Start: March 12, 2019
• Primary Completion: February 22, 2022
• Study Completion: December 1, 2022
• Last Updated: May 24, 2024
• Results First Posted: May 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)