---
title: Study of Autologous T-cells in Patients With Metastatic Pancreatic Cancer
nct_id: NCT03638193
overall_status: UNKNOWN
phase: NA
sponsor: Shenzhen BinDeBio Ltd.
study_type: INTERVENTIONAL
primary_condition: Pancreatic Cancer
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03638193.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03638193"
ct_last_update_post_date: 2021-02-04
last_seen_at: "2026-05-12T06:39:06.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Study of Autologous T-cells in Patients With Metastatic Pancreatic Cancer

**Official Title:** Study of Autologous T-cells Redirected to Mesothelin With a Chimeric Antigen Receptor in Patients With Metastatic Pancreatic Cancer

**NCT ID:** [NCT03638193](https://clinicaltrials.gov/study/NCT03638193)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 10
- **Lead Sponsor:** Shenzhen BinDeBio Ltd.
- **Collaborators:** The First Affiliated Hospital with Nanjing Medical University
- **Conditions:** Pancreatic Cancer
- **Start Date:** 2018-07-11
- **Completion Date:** 2022-02-01
- **CT.gov Last Update:** 2021-02-04

## Brief Summary

This is a study in which pancreatic cancer patients receive a immunotherapy with CART-meso cells administered at 3 days after one dose of cyclophosphamide. CART-meso cells are patients' own T cells lentivirally transduced to express anti-mesothelin scFv fused to TCRζ and 4-1BB costimulatory domains.The lymphodepletion with cyclophosphamide may prolong the persistence of CART cells.

## Detailed Description

This study is being conducted to assess the safety and efficacy of immunotherapy with CART-meso cells in dose escalation design. The trial will begin in Cohort 1 and progress to Cohorts 2, depending upon dose limiting toxicity (DLT) assessment .

Subjects will be enrolled serially, but infusions will be staggered to allow assessment of DLTs for determination of cohort progression, expansion, or dose de-escalation.

Cohort 1 subjects will receive a single dose of 1-3x10\^7 /m\^2 lentiviral transduced CART-meso cells after conditioning chemotherapeutic regimen.

Cohort 2 subjects will receive a single dose of 1-3x10\^8 /m\^2 lentiviral transduced CART-meso cells cells after conditioning chemotherapeutic regimen.

Dose limiting toxicity is defined as any adverse reactions at level 3 or above that may be associated with CART-meso within 4 weeks after infusion.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 70 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Signed informed consent
* Unresectable or metastatic pancreatic cancer
* Persistent cancer after at least one prior standard of care chemotherapy for advanced stage disease
* 18 - 70 years of age
* ECOG performance status of 0 or 1
* Life expectancy greater than 3 months
* Satisfactory organ and bone marrow function
* Meets blood coagulation parameters
* Male and Female subjects of reproductive potential agree to use approved contraceptive methods

Exclusion Criteria:

* Participation in a therapeutic investigational study within 4 weeks prior to the screening visit
* Anticipated need for systemic chemotherapy within 2 weeks before apheresis and infusion
* Active invasive cancer other than pancreatic cancer
* HIV, HCV, or HBV infections
* Active autoimmune disease requiring immunosuppressive therapy within 4 weeks prior to screening visit, with exception of thyroid replacement
* Ongoing or active infection
* Planned concurrent treatment with systemic high dose corticosteroids
* Patients requiring supplemental oxygen therapy
* Prior therapy with gene modified cells
* Previous experimental therapy with SS1 moiety, murine or chimeric antibodies
* History of allergy to murine proteins
* History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40)
* Clinically significant pericardial effusion, CHF, or cardiovascular condition that would preclude assessment of mesothelin induced pericarditis or that may worsen as a result of toxicities expected for this study
* Pregnant or breastfeeding women
```

## Arms

- **CART-meso cells** (EXPERIMENTAL) — A single dose of CART-meso T cells will be administered intravenously.The dose is 1-3×10\^7/m\^2 CART positive cells(chort 1)or 1-3×10\^8/m\^2 CART positive cells(chort 2).

## Interventions

- **CART-meso cells** (BIOLOGICAL) — CART-meso is a 2nd CAR, with mesothelin as target protein, 4-1BB as co- stimulator. The infusion will be scheduled to occur 3 (±1) days after a single dose of 1.5 grams/m\^2 of cyclophosphamide, which will be administered according to standard procedures, Thereby enhancing the efficacy of anti-tumor, reducing the potential of side effects.

## Primary Outcomes

- **Safety of CART-meso infusion: number of adverse events** _(time frame: 60 months)_ — Number of Adverse Events evaluated with NCI CTC AE, version 4.0\[Safety evaluation\]

## Secondary Outcomes

- **Clinical response of CART-meso** _(time frame: 60 months)_
- **CAR-T cell detection** _(time frame: 60 months)_

## Locations (1)

- Nanjing First Hospital, Nanjing, Jiangsu, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — 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.nanjing first hospital|nanjing|jiangsu|china` — added _(2026-05-12)_

---

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