---
title: Analyzing Childhood Recall Antigens in Patients With Pancreatic Cancer
nct_id: NCT03848182
overall_status: TERMINATED
phase: PHASE2
sponsor: Albert Einstein College of Medicine
study_type: INTERVENTIONAL
primary_condition: Pancreatic Cancer
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03848182.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03848182"
ct_last_update_post_date: 2024-04-18
last_seen_at: "2026-05-12T06:56:36.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Analyzing Childhood Recall Antigens in Patients With Pancreatic Cancer

**Official Title:** Analysis of T Cells to Tetanus Toxoid Antigens in Patients With Pancreatic Cancer Treated With Gemcitabine

**NCT ID:** [NCT03848182](https://clinicaltrials.gov/study/NCT03848182)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Slow accrual
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 10
- **Lead Sponsor:** Albert Einstein College of Medicine
- **Collaborators:** Pancreatic Cancer Action Network
- **Conditions:** Pancreatic Cancer
- **Start Date:** 2017-07-21
- **Completion Date:** 2019-11-11
- **CT.gov Last Update:** 2024-04-18

## Brief Summary

The investigator is developing an immune therapy against pancreatic cancer. Immune cells, known as "T cells with tumor killing capacity", are involved in this immune therapy. In mice with pancreatic cance there is evidence that one tetanus toxoid (TT) vaccination (that patients receive from childhood) combined with Gemcitabine activates these killer T cells. (Gemcitabine improves T cell responses) These killer T cells are able to destroy tumor cells uploaded with TT protein (such studies are planned in future clinical trials). The goal of this study is to test whether one TT vaccination combined with Gemcitabine treatment activates the same T cells in pancreatic cancer patients.

## Detailed Description

Treating PDAC patients with gemcitabine and one TT booster Gemcitabine will be delivered as is standard of care. However, doses may be modified by the treating physician based on patient tolerance. Patients diagnosed with PDAC will be treated with Gemcitabine and boosted once with the human childhood vaccine to TT by Dr. Chuy as outlined in Fig 2. Gemcitabine will be administered on days 1, 8, 15 every 28 days, and one booster with the human TT childhood vaccine will be administered on day 8 (there must be 2 hrs between the TT booster and the Gemcitabine treatment). Blood will be drawn just before each Gemcitabine treatment, except on day 8 at least 2 hrs will be needed between the blood draw and Gemcitabine treatment because the TT booster needs to be given just after the blood draw but 2 hrs before the Gemcitabine treatment (Fig 2). Three tubes of 10 mls each with heparinized blood will be needed for the isolation of peripheral blood mononuclear cells (PBMC). Two tubes will be used to analyze the T cells and one tube for analyzing the MDSC. The memory T cells and MDSC will be analyzed in the laboratory of Dr. Gravekamp.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 100 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

1. Histologically or cytologically confirmed adenocarcinoma of the pancreas
2. Patients is a candidate for gemcitabine chemotherapy (adjuvant, metastatic, locally advanced, borderline resectable settings all permitted)
3. Patients at least 18 years of age
4. ECOG performance status 0-2
5. Consent to donate 12 tubes of peripheral blood of 10 mL each
6. Adequate organ function as defined as -neutrophil count ≥ 1200 -platelets ≥ 75,000 -hemoglobin ≥ 8.0 -bilirubin ≤ 2.0 -creatinine ≤2.0 or calculated GFR ≥ 30
7. Ability to understand and willingness to sign a written informed consent document
8. Prior chemotherapy permitted, as long as 60 days have lapsed since last dose. Prior radiation therapy permitted, as long as 28 days lapsed since last treatment.
9. Patients may receive other concurrent chemotherapy, immunotherapy, or radiotherapy

Exclusion Criteria:

1. Patients never been immunized with tetanus toxoid (TT). Patients with a history of adverse reaction to tetanus vaccine (with the exception of self-limited fever or local tissue reaction
2. Patients may not be receiving any investigational agents
3. Pregnant women
4. Patients with HIV
```

## Arms

- **Gemcitabine with TT vaccine booster** (EXPERIMENTAL) — Gemcitabine will be delivered as is standard of care. Patients diagnosed with pancreatic ductal carcinoma (PCD) will be treated with Gemcitabine and boosted once with the human childhood vaccine to TT

## Interventions

- **Gemcitabine** (DRUG) — Gemcitabine will be administered on days 1, 8, 15 every 28 days
- **TT vaccine booster** (BIOLOGICAL) — One human TT childhood vaccine booster will be administered on day 8

## Primary Outcomes

- **Change in CD4 T Cell Responses Before TT Booster** _(time frame: Day 1)_ — The relative difference in CD4 T cell counts before and after administration of the TT booster vaccine (Day 8) will be compared. The number of cells per microliter (cells/µL) will be determined. The proportion of at least 3-fold increase will be reported along with its 95% CI. The actual magnitude of change will be examined by taking a log scale of CD4 counts and report a mean of change on CD4 on its log scale along with its 95% CI.
- **Change in CD4 T Cell Responses Before TT Booster** _(time frame: Day 8)_ — The relative difference in CD4 T cell counts before and after administration of the TT booster vaccine (Day 8) will be compared. The number of cells per microliter (cells/µL) will be determined. The proportion of at least 3-fold increase will be reported along with its 95% CI. The actual magnitude of change will be examined by taking a log scale of CD4 counts and report a mean of change on CD4 on its log scale along with its 95% CI.
- **Change in CD4 T Cell Responses After TT Booster** _(time frame: Day 15)_ — The relative difference in CD4 T cell counts before and after administration of the TT booster vaccine (Day 8) will be compared. The number of cells per microliter (cells/µL) will be determined. The proportion of at least 3-fold increase will be reported along with its 95% CI. The actual magnitude of change will be examined by taking a log scale of CD4 counts and report a mean of change on CD4 on its log scale along with its 95% CI.
- **Change in CD4 T Cell Responses After TT Booster** _(time frame: Day 28)_ — The relative difference in CD4 T cell counts before and after administration of the TT booster vaccine (Day 8) will be compared. The number of cells per microliter (cells/µL) will be determined. The proportion of at least 3-fold increase will be reported along with its 95% CI. The actual magnitude of change will be examined by taking a log scale of CD4 counts and report a mean of change on CD4 on its log scale along with its 95% CI.

## Secondary Outcomes

- **Change in CD8 T Cell Responses Before TT Booster** _(time frame: Day 1)_
- **Change in CD8 T Cell Responses Before TT Booster Vaccine** _(time frame: Day 8)_
- **Change in CD8 T Cell Responses After TT Booster** _(time frame: Day 15)_
- **Change in CD8 T Cell Responses After TT Booster** _(time frame: Day 28)_

## Locations (1)

- Albert Einstein College of Medicine, The Bronx, New York, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.albert einstein college of medicine|the bronx|new york|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03848182.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03848182*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*