TAA Specific Cytotoxic T Lymphocytes in Patients With Pancreatic Cancer — TACTOPS  

Pancreatic Cancer Clinical Trial

Official title: Tumor-Associated Antigen (TAA) Specific Cytotoxic T Lymphocytes Administered in Patients With Pancreatic Cancer

Status Active, not recruiting

Clinical Trial 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.*

Clinical Trial Description

Status - CLOSED TO PATIENT ENROLLMENT (CNPE)

The patient will give blood to make TAA-Specific cytotoxic T cells in a lab. These cells well be grown and frozen. If the TAA-Specific cytotoxic T cells can be made, the time from collection of the blood to manufacture of T cells for administration to the patient is about 1 to 2 months.

The cells will be infused by intravenous infusion (IV) into the patient over 1-10 minutes. The patient may be pre-treated with acetaminophen (Tylenol) and diphenhydramine (Benadryl). Acetaminophen (Tylenol) and diphenhydramine (Benadryl) are given to prevent a possible allergic reaction to the TAA-CTL administration.

Patients will be given up to six doses of TAA-CTLs at monthly intervals. The treatments will be given by the Center for Cell and Gene Therapy at Houston Methodist Hospital (HMH).

MEDICAL TESTS BEFORE TREATMENT:

• Physical exam.

• Blood tests to measure blood cells, kidney and liver function.

• Measurements of the patient's tumor by routine imaging studies and/or blood tests. The study will use the imaging study that was used before to follow the patient's tumor: CT, MRI, or PET.

• Blood test to check for pregnancy for female patients who can have children

MEDICAL TESTS DURING TREATMENT:

Standard medical tests will be conducted on the day of the second and subsequent infusions:

• Physical exams prior to each T cell infusion

• Blood tests to measure blood cells, kidney and liver function.

MEDICAL TESTS AFTER TREATMENT:

• Measurements the patient's tumor by routine imaging studies and/or blood tests done as per standard of care.

To learn more about the way the TAA-CTLs are working in patient's body, an extra 20-40 mL (4-8 teaspoons) of blood will be taken before the infusion, at Weeks 1 and 2 after each infusion and at weeks 4, 6 and 8 and months 3, 6, 9 and 12 after the last infusion. The blood may be drawn from a central line at the time of the patient's regular blood tests. Investigators will use this blood to see how long the TAA-CTLs last, and to look at the immune system response to the patient's cancer.

Study Duration: Patients will be active participants in this study for approximately one year after their last dose. Investigators will contact patients once a year for up to 4 additional years (total of 5 years follow-up) in order to evaluate disease response long-term.

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

• NCT number: NCT03192462
• Study type: Interventional
• Source: Baylor College of Medicine
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: January 18, 2018
• Completion date: May 1, 2027