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TAA Specific Cytotoxic T Lymphocytes in Patients With Pancreatic Cancer

NCT03192462 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2025-10-29

Study results available
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Summary

Status - CLOSED TO PATIENT ENROLLMENT (CNPE)

Patients who have pancreatic cancer that has come back or has not gone away after treatment, including the standard treatment for this disease or patients who are not eligible for or have elected not to receive standard of care chemotherapy, and patients who will have surgery after treatment for pancreatic cancer are eligible for this study. This is a research study using special immune system cells called tumor-associated antigen (TAA)-specific cytotoxic T lymphocytes, a new experimental therapy.

The proteins that are targeted in this study are called tumor-associated antigens (TAAs). These are cell proteins that are specific to the cancer cell. They do not show, or they show up in low quantities, on normal human cells. In this study, five common TAAs will be targeted. They are called NY-ESO-1, MAGEA4, PRAME, Survivin and SSX2. On a different study, patients have been treated and so far this treatment has shown to be safe.

Investigators now want to try this treatment in patients with pancreatic cancer.

These TAA-specific cytotoxic T lymphocytes (TAA-CTLs) are an investigational product not approved by the Food and Drug Administration.

\*Arm A and Arm B are closed to new patient enrollment.\*

Conditions

Interventions

BIOLOGICAL

multiTAA specific T cells

Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10\^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc.

Sponsors & Collaborators

  • Center for Cell and Gene Therapy, Baylor College of Medicine

    collaborator OTHER

  • The Methodist Hospital Research Institute

    collaborator OTHER

  • Pancreatic Cancer Action Network

    collaborator OTHER

  • The V Foundation for Cancer Research

    collaborator OTHER

  • Harris County Hospital District

    collaborator OTHER_GOV

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Anne Leen, PhD · Baylor College of Medicine

  • Benjamin Musher, MD · Baylor College of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-18
Primary Completion
2020-06-15
Completion
2025-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03192462 on ClinicalTrials.gov